Brain Injuries, TraumaticNCT02589509
Cognitive Rehabilitation and Brain Activity of Attention Control in TBI
A study testing Direct-attention training using web-based BrainHQ and Goal Management Training (GMT) in people with Brain Injuries, Traumatic, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this study is to test an innovative combination of direct-attention training and metacognitive training in the treatment of attention impairments in Veterans with moderate-to-severe traumatic brain injury (TBI) who report experiencing attentional problems. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- Direct-attention training using web-based BrainHQ and Goal Management Training (GMT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2015to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- OEF/OIF/OND Veterans with moderate or severe TBI as described by DOD/VA common definition.
- Self-report of attentional problems, confirmed with psychometric testing.
- Ruff 2 \& 7 selective attention task score <= 1.5 standard deviations from demographically-matched norms.
- Able to participate in study at 12-60 months post injury without contraindications.
- Age 21-55 years.
- Willingness to be randomized and to participate in treatment procedures.
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- Capacity to visit the laboratory for repeated treatment and testing sessions.
- Access to internet-enabled home computer.
- English as Native language.
- Adequate reading comprehension to allow completion of study-related questionnaires.
- Reliable digit span (RDS) score > 7.
Who cannot join
- Pre-existing neurological disorder associated with cerebral dysfunction (e.g., stroke, history of epilepsy or chronic seizure disorder).
- Current alcohol or drug use/dependence.
- Pre-existing severe psychiatric disorder (e.g., schizophrenia, bipolar disorder) or history of psychiatric diagnosis sufficiently severe to have resulted in inpatient hospitalization.
- Current suicidal or homicidal ideation.
- Reported involvement in current litigation.
- Reported history of pre-injury learning disability.
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- Not competent to provide written informed consent (i.e., not able to demonstrate understanding or expectations of study and potential risks of participation).
- Does not fully understand the nature of the study and requirements of participation.
- Does not understand task instructions.
- Validity testing score on RDS <= 7.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608
About this study
Official title: Cognitive Rehabilitation and Brain Activity of Attention-Control Impairment in TBI
The purpose of this study is to test an innovative combination of direct-attention training and metacognitive training in the treatment of attention impairments in Veterans with moderate-to-severe traumatic brain injury (TBI) who report experiencing attentional problems. Enrolled participants will be randomized to receive either the direct-attention training or metacognitive training first and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods of 4 weeks and a post-treatment 4 weeks later. In addition to the rehabilitation treatments, participants will also perform measures of complex functional activities (e.g., independent activities of daily living or IADLs) and neurocognitive tests of attention-control functions. Participants will also perform an attentional task that probes the function of three different attentional systems while brain wave activity (i.e., electroencephalography or EEG) is being recorded in order to assess changes in brain function that may be improved by the rehabilitation approach. Planned enrollment will be 36 Veterans.
Read the detailed description
Attention impairment is ubiquitous in TBI survivors. This is a devastating impairment because attention is the backbone of cognitive systems. Attention is requisite for other cognitive processes that are vital to everyday functioning such as memory, problem solving, language skills, and the cognitive control of behavior. Studies of attention training have shown improved attention on laboratory measures, but limited translation to real-world tasks. Notably, these previously-tested rehabilitation approaches have not included training in the very cognitive processes needed for translation of training to everyday tasks which include internal verbalization and self-monitoring, also called metacognitive strategies. One training method for metacognitive strategies has shown promise, but is lacking in basic attention training. Rehabilitation specialists have recently argued for a rehabilitation approach wherein both basic foundational attention and metacognitive strategies should be synergistically combined. Consequently, the investigators will test an innovative combination of direct-attention training and metacognitive training for which the other compensates disadvantages of each. Because of the promise of each type of training separately, and the potential additive effects of the combination, it is critical to test this combined attention and metacognitive training in Veteran survivors of chronic moderate-to-severe traumatic brain injury (TBI). The investigators will address the following two specific aims: the investigators propose to conduct a pilot study to examine cognitive rehabilitation therapy (CRT) effects in a group of Veterans with chronic moderate to severe TBI (m/sTBI), focused on remediating attention-control impairments using both direct-attention and metacognitive-strategy training approaches in a AB/BA crossover design with 1-month follow-up to address the following two specific aims: 1) Test treatment response to combined direct-attention and metacognitive-strategy training in Veterans with chronic m/sTBI; and 2) identify mechanisms and biomarkers of rehabilitation-related neuroplasticity. Under the first aim the investigators will test for effects of combined direct-attention and metacognitive-strategy training on measures of complex functional activities and neurocognitive tests of attention-control functions. Under the second aim, the investigators will test effects of the their CRT approach on behavioral and brain activity while participants perform a well-validated attentional task that probes the function of three dissociable attentional systems. The approach is innovative because it combines a theoretically motivated and novel approach to address a significant source of disability in Veteran survivors of TBI. The proposed research is significant because findings will form the foundation for a larger-scale trial to enable us to determine the durability of gains and the functional impact of treatment on Veteran's real world activities and to more positively shape healthcare for our Veterans who are suffering from TBI. Outcome measures will include standardized tests of neurocognitive functioning such as attention and other cognitive skills, measures of self care, ability to live independently, social role participation, life satisfaction, TBI-related quality of life, mood/anxiety, and attention-related scalp-recorded brain event-related potentials (ERPs, derived from electroencephalography).
- Conditions
- Brain Injuries, Traumatic
- Being tested
- Direct-attention training using web-based BrainHQ, Goal Management Training (GMT)
- Keywords
- Event-related potentials, Attention, Cognitive rehabilitation, Independent activities of daily living
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct-attention training using web-based BrainHQBehavioural
BrainHQ (by Posit Science Corp.) computerized attention training using the following modules: "Divided attention," "Target tracker," "Double Decision," "Mixed Signals," and "Freeze Frame."
Goal Management Training (GMT)Behavioural
A compensatory metacognitive strategy-based intervention program that teaches strategies for improving attentional control and problem solving.
| Study group | Role | What they receive |
|---|---|---|
| Direct-Metacognitive | Experimental | Direct attention training followed by metacognitive strategy training Receives: Behavioral: Direct-attention training using web-based BrainHQ; Behavioral: Goal Management Training (GMT) |
| Metacognitive-Direct | Experimental | Metacognitive strategy training followed by direct-attention training Receives: Behavioral: Direct-attention training using web-based BrainHQ; Behavioral: Goal Management Training (GMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Instrumental Activities of Daily Living (TIADL)
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.
Measured: Baseline TIADL Reaction Time assessed pretreatment
Timed Instrumental Activities of Daily Living (TIADL)
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.
Measured: Change from Baseline in TIADL Reaction Time assessed at 8 weeks
Timed Instrumental Activities of Daily Living (TIADL)
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.
Measured: Change from Baseline in TIADL Reaction Time assessed at 12 weeks (1-month post treatment)
Timed Instrumental Activities of Daily Living (TIADL) - Accuracy
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.
Measured: Change from Baseline in TIADL Accuracy assessed at 4 weeks
Timed Instrumental Activities of Daily Living (TIADL) - Accuracy
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.
Measured: Change from Baseline in TIADL Accuracy assessed at 8 weeks
Timed Instrumental Activities of Daily Living (TIADL) - Accuracy
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.
Measured: Change from Baseline in TIADL Accuracy assessed at 12 weeks (1 month post treatment)
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Ability Score
Assesses global outcome, including ability, adjustment and community participation indices.
Measured: Change from Baseline in MPAI-4 Ability Score assessed at 4 weeks
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Ability Score
Assesses global outcome, including ability, adjustment and community participation indices.
Measured: Change from Baseline in MPAI-4 Ability Score assessed at 8 weeks
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Ability Score
Assesses global outcome, including ability, adjustment and community participation indices.
Measured: Change from Baseline in MPAI-4 Ability Score assessed at 12 weeks (1 month post treatment)
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Adjustment Score
Assesses global outcome, including ability, adjustment and community participation indices.
Measured: Change from Baseline in MPAI-4 Adjustment Score assessed at 4 weeks
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Adjustment Score
Assesses global outcome, including ability, adjustment and community participation indices.
Measured: Change from Baseline in MPAI-4 Adjustment Score assessed at 8 weeks
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Adjustment Score
Assesses global outcome, including ability, adjustment and community participation indices.
Measured: Change from Baseline in MPAI-4 Adjustment Score assessed at 12 weeks (1 month post treatment)
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Participation Score
Assesses global outcome, including ability, adjustment and community participation indices.
Measured: Change from Baseline in MPAI-4 Participation Score assessed at 4 weeks
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Participation Score
Assesses global outcome, including ability, adjustment and community participation indices.
Measured: Change from Baseline in MPAI-4 Participation Score assessed at 8 weeks
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Participation Score
Assesses global outcome, including ability, adjustment and community participation indices.
Measured: Change from Baseline in MPAI-4 Participation Score assessed at 12 weeks (1 month post treatment)
Timed Instrumental Activities of Daily Living (TIADL) - Reaction Time score
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.
Measured: Baseline (pretreatment) on TIADL - Reaction Time score
Timed Instrumental Activities of Daily Living (TIADL) - Accuracy score
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.
Measured: Baseline (pretreatment) on TIADL - Accuracy score
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4)
Assesses global outcome, including ability, adjustment and community participation indices. The MPAI-4 is a 35-item questionnaire-based inventory that will be completed study staff and TBI survivors. It offers three subscales (Ability, Adjustment, and Participation) and has well-documented psychometric properties. MPAI-4 items represent the range of physical, cognitive, emotional, behavioral, and societal problems that TBI survivors often encounter; it also assess major obstacles to community integration.
Measured: Baseline (pretreatment) MPAI-4 Adjustment score
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4)
Assesses global outcome, including ability, adjustment and community participation indices. The MPAI-4 is a 35-item questionnaire-based inventory that will be completed study staff and TBI survivors. It offers three subscales (Ability, Adjustment, and Participation) and has well-documented psychometric properties. MPAI-4 items represent the range of physical, cognitive, emotional, behavioral, and societal problems that TBI survivors often encounter; it also assess major obstacles to community integration.
Measured: Baseline (pretreatment) MPAI-4 Participation score
Attention Network Test (ANT) Alerting Reaction Time score
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Measured: Change from Baseline in Altering Reaction Time Score assessed at 4 weeks
Attention Network Test (ANT) Alerting Reaction Time score
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Measured: Change from Baseline in Altering Reaction Time Score assessed at 8 weeks
Attention Network Test (ANT) Alerting Reaction Time score
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Measured: Change from Baseline in Altering Reaction Time Score assessed at 12 weeks (1 month post treatment)
Attention Network Test (ANT) Orient Reaction Time score
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Measured: Baseline (pretreatment) Orienting Reaction Time score
Attention Network Test (ANT) Orienting Reaction Time score
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Measured: Change from Baseline in Orienting Reaction Time Score assessed at 4 weeks
Attention Network Test (ANT) Orienting Reaction Time score
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Measured: Change from Baseline in Orienting Reaction Time Score assessed at 8 weeks
Attention Network Test (ANT) Orienting Reaction Time score
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Measured: Change from Baseline in Orienting Reaction Time Score assessed at 12 weeks (1 month post treatment)
Attention Network Test (ANT) Executive-Control Reaction Time score
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Measured: Baseline (pretreatment) Executive-Control Reaction Time score
Attention Network Test (ANT) Executive-Control Reaction Time score
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Measured: Change from Baseline in Executive-Control Reaction Time Score assessed at 4 weeks
Attention Network Test (ANT) Executive-Control Reaction Time score
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Measured: Change from Baseline in Executive-Control Reaction Time Score assessed at 8 weeks
Attention Network Test (ANT) Executive-Control Reaction Time score
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Measured: Change from Baseline in Executive-Control Reaction Time Score assessed at 12 weeks (1 month post treatment)
Attention Network Test (ANT) Alerting Reaction Time score
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Measured: Baseline (pretreatment) Alerting Reaction Time score
ANT ERP (N1) Alerting Amplitude
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Measured: Baseline ANT ERP (N1) Alerting Amplitude assessed pretreatment
ANT ERP (N1) Alerting Amplitude
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Measured: Change from Baseline in ANT ERP (N1) Alerting Amplitude assessed at 4 weeks
ANT ERP (N1) Alerting Amplitude
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Measured: Change from Baseline in ANT ERP (N1) Alerting Amplitude assessed at 8 weeks
ANT ERP (N1) Alerting Amplitude
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Measured: Change from Baseline in ANT ERP (N1) Alerting Amplitude assessed at 12 weeks (1 month post treatment)
ANT ERP (N1) Orienting Amplitude
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Measured: Baseline ANT ERP (N1) Orienting Amplitude assessed pretreatment
ANT ERP (N1) Orienting Amplitude
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Measured: Change from Baseline in ANT ERP (N1) Orienting Amplitude assessed at 4 weeks
ANT ERP (N1) Orienting Amplitude
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Measured: Change from Baseline in ANT ERP (N1) Orienting Amplitude assessed at 8 weeks
ANT ERP (N1) Orienting Amplitude
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Measured: Change from Baseline in ANT ERP (N1) Orienting Amplitude assessed at 12 weeks (1 month post treatment)
ANT ERP (P3) Executive Amplitude
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Measured: Baseline ANT ERP (P3) Executive Amplitude assessed pretreatment
ANT ERP (P3) Executive Amplitude
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Measured: Baseline ANT ERP (P3) Executive Amplitude assessed at 4 weeks
ANT ERP (P3) Executive Amplitude
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Measured: Baseline ANT ERP (P3) Executive Amplitude assessed at 8 weeks
ANT ERP (P3) Executive Amplitude
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Measured: Baseline ANT ERP (P3) Executive Amplitude assessed at 12 weeks (1 month post treatment)
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Ability Score
Assesses global outcome, including ability, adjustment and community participation indices. The MPAI-4 is a 35-item questionnaire-based inventory that will be completed study staff and TBI survivors. It offers three subscales (Ability, Adjustment, and Participation) and has well-documented psychometric properties. MPAI-4 items represent the range of physical, cognitive, emotional, behavioral, and societal problems that TBI survivors often encounter; it also assess major obstacles to community integration.
Measured: Baseline MPAI-4 Ability Score assessed pretreatment
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Adjustment Score
Assesses global outcome, including ability, adjustment and community participation indices. The MPAI-4 is a 35-item questionnaire-based inventory that will be completed study staff and TBI survivors. It offers three subscales (Ability, Adjustment, and Participation) and has well-documented psychometric properties. MPAI-4 items represent the range of physical, cognitive, emotional, behavioral, and societal problems that TBI survivors often encounter; it also assess major obstacles to community integration.
Measured: Baseline MPAI-4 Adjustment Score assessed pretreatment
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Participation Score
Assesses global outcome, including ability, adjustment and community participation indices. The MPAI-4 is a 35-item questionnaire-based inventory that will be completed study staff and TBI survivors. It offers three subscales (Ability, Adjustment, and Participation) and has well-documented psychometric properties. MPAI-4 items represent the range of physical, cognitive, emotional, behavioral, and societal problems that TBI survivors often encounter; it also assess major obstacles to community integration.
Measured: Baseline MPAI-4 Participation Score assessed pretreatment
Secondary outcomes (8)
Mindful Attention Awareness Scale-Lapses Only (MAAS-LO)
The MAAS-LO is a 12-item 6-point Likert-type scale designed to measure everyday attentional lapses (infrequent to very frequent).
Measured: Change from Baseline in MAAS-LO Score assessed at 4 weeks
Mindful Attention Awareness Scale-Lapses Only (MAAS-LO)
The MAAS-LO is a 12-item 6-point Likert-type scale designed to measure everyday attentional lapses (infrequent to very frequent).
Measured: Change from Baseline in MAAS-LO Score assessed at 8 weeks
Mindful Attention Awareness Scale-Lapses Only (MAAS-LO)
The MAAS-LO is a 12-item 6-point Likert-type scale designed to measure everyday attentional lapses (infrequent to very frequent).
Measured: Change from Baseline in MAAS-LO Score assessed at 12 weeks (1 month post treatment)
Satisfaction with Life Scale (SWLS)
The SWLS assesses patient's perceived satisfaction with life. It is a 5-item 7-point Likert-type scale with a range from "strongly disagree" to "strongly agree." The total score is used as a measure of satisfaction with life.
Measured: Baseline SWLS Score assessed pretreatment
Mindful Attention Awareness Scale-Lapses Only (MAAS-LO)
The MAAS-LO is a 12-item 6-point Likert-type scale designed to measure everyday attentional lapses (infrequent to very frequent).
Measured: Baseline (pretreatment) on MAAS-LO
Satisfaction with Life Scale (SWLS)
The SWLS assesses patient's perceived satisfaction with life. It is a 5-item 7-point Likert-type scale with a range from "strongly disagree" to "strongly agree." The total score is used as a measure of satisfaction with life.
Measured: Change from Baseline in SWLS Score assessed at 4 weeks
Satisfaction with Life Scale (SWLS)
The SWLS assesses patient's perceived satisfaction with life. It is a 5-item 7-point Likert-type scale with a range from "strongly disagree" to "strongly agree." The total score is used as a measure of satisfaction with life.
Measured: Change from Baseline in SWLS Score assessed at 8 weeks
Satisfaction with Life Scale (SWLS)
The SWLS assesses patient's perceived satisfaction with life. It is a 5-item 7-point Likert-type scale with a range from "strongly disagree" to "strongly agree." The total score is used as a measure of satisfaction with life.
Measured: Change from Baseline in SWLS Score assessed at 12 weeks (1 month post treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study start1 Dec 2015
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Why it stopped: No one was recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- William M Perlstein, PhD, Principal investigator, North Florida/South Georgia Veterans Health System, Gainesville, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589509
- Sponsor's protocol ID
- N1920-P
- Other IDs
- I21RX001920-01A1
- Status last verified
- Feb 2022
- First submitted
- 13 Oct 2015
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Rehabilitation and Brain Activity of Attention-Control Impairment in TBI
- ClinicalTrials.gov ID
- NCT02589509
- Acronym / sponsor ID
- N1920-P
- Conditions
- Brain Injuries, Traumatic
- Keywords
- Event-related potentials, Attention, Cognitive rehabilitation, Independent activities of daily living
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No one was recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test an innovative combination of direct-attention training and metacognitive training in the treatment of attention impairments in Veterans with moderate-to-severe traumatic brain injury (TBI) who report experiencing attentional problems. Enrolled participants will be randomized to receive either the direct-attention training or metacognitive training first and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods of 4 weeks and a post-treatment 4 weeks later. In addition to the rehabilitation treatments, participants will also perform measures of complex functional activities (e.g., independent activities of daily living or IADLs) and neurocognitive tests of attention-control functions. Participants will also perform an attentional task that probes the function of three different attentional systems while brain wave activity (i.e., electroencephalography or EEG) is being recorded in order to assess changes in brain function that may be improved by the rehabilitation approach. Planned enrollment will be 36 Veterans.
Detailed description
Attention impairment is ubiquitous in TBI survivors. This is a devastating impairment because attention is the backbone of cognitive systems. Attention is requisite for other cognitive processes that are vital to everyday functioning such as memory, problem solving, language skills, and the cognitive control of behavior. Studies of attention training have shown improved attention on laboratory measures, but limited translation to real-world tasks. Notably, these previously-tested rehabilitation approaches have not included training in the very cognitive processes needed for translation of training to everyday tasks which include internal verbalization and self-monitoring, also called metacognitive strategies. One training method for metacognitive strategies has shown promise, but is lacking in basic attention training. Rehabilitation specialists have recently argued for a rehabilitation approach wherein both basic foundational attention and metacognitive strategies should be synergistically combined. Consequently, the investigators will test an innovative combination of direct-attention training and metacognitive training for which the other compensates disadvantages of each. Because of the promise of each type of training separately, and the potential additive effects of the combination, it is critical to test this combined attention and metacognitive training in Veteran survivors of chronic moderate-to-severe traumatic brain injury (TBI). The investigators will address the following two specific aims: the investigators propose to conduct a pilot study to examine cognitive rehabilitation therapy (CRT) effects in a group of Veterans with chronic moderate to severe TBI (m/sTBI), focused on remediating attention-control impairments using both direct-attention and metacognitive-strategy training approaches in a AB/BA crossover design with 1-month follow-up to address the following two specific aims: 1) Test treatment response to combined direct-attention and metacognitive-strategy training in Veterans with chronic m/sTBI; and 2) identify mechanisms and biomarkers of rehabilitation-related neuroplasticity. Under the first aim the investigators will test for effects of combined direct-attention and metacognitive-strategy training on measures of complex functional activities and neurocognitive tests of attention-control functions. Under the second aim, the investigators will test effects of the their CRT approach on behavioral and brain activity while participants perform a well-validated attentional task that probes the function of three dissociable attentional systems. The approach is innovative because it combines a theoretically motivated and novel approach to address a significant source of disability in Veteran survivors of TBI. The proposed research is significant because findings will form the foundation for a larger-scale trial to enable us to determine the durability of gains and the functional impact of treatment on Veteran's real world activities and to more positively shape healthcare for our Veterans who are suffering from TBI. Outcome measures will include standardized tests of neurocognitive functioning such as attention and other cognitive skills, measures of self care, ability to live independently, social role participation, life satisfaction, TBI-related quality of life, mood/anxiety, and attention-related scalp-recorded brain event-related potentials (ERPs, derived from electroencephalography).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct-Metacognitive | Experimental | Behavioral: Direct-attention training using web-based BrainHQ, Behavioral: Goal Management Training (GMT)Direct attention training followed by metacognitive strategy training |
| Metacognitive-Direct | Experimental | Behavioral: Direct-attention training using web-based BrainHQ, Behavioral: Goal Management Training (GMT)Metacognitive strategy training followed by direct-attention training |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- OEF/OIF/OND Veterans with moderate or severe TBI as described by DOD/VA common definition.
- Self-report of attentional problems, confirmed with psychometric testing.
- Ruff 2 \& 7 selective attention task score <= 1.5 standard deviations from demographically-matched norms.
- Able to participate in study at 12-60 months post injury without contraindications.
- Age 21-55 years.
Key exclusion criteria (10 listed)
- Pre-existing neurological disorder associated with cerebral dysfunction (e.g., stroke, history of epilepsy or chronic seizure disorder).
- Current alcohol or drug use/dependence.
- Pre-existing severe psychiatric disorder (e.g., schizophrenia, bipolar disorder) or history of psychiatric diagnosis sufficiently severe to have resulted in inpatient hospitalization.
- Current suicidal or homicidal ideation.
- Reported involvement in current litigation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct-attention training using web-based BrainHQBrainHQ (by Posit Science Corp.) computerized attention training using the following modules: "Divided attention," "Target tracker," "Double Decision," "Mixed Signals," and "Freeze Frame." | Behavioural | Direct-Metacognitive, Metacognitive-Direct |
| Goal Management Training (GMT)A compensatory metacognitive strategy-based intervention program that teaches strategies for improving attentional control and problem solving. | Behavioural | Direct-Metacognitive, Metacognitive-Direct |
Primary outcome
Timed Instrumental Activities of Daily Living (TIADL)
Time frame: Baseline TIADL Reaction Time assessed pretreatment
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.
Timed Instrumental Activities of Daily Living (TIADL)
Time frame: Change from Baseline in TIADL Reaction Time assessed at 8 weeks
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.
Timed Instrumental Activities of Daily Living (TIADL)
Time frame: Change from Baseline in TIADL Reaction Time assessed at 12 weeks (1-month post treatment)
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.
Timed Instrumental Activities of Daily Living (TIADL) - Accuracy
Time frame: Change from Baseline in TIADL Accuracy assessed at 4 weeks
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.
Timed Instrumental Activities of Daily Living (TIADL) - Accuracy
Time frame: Change from Baseline in TIADL Accuracy assessed at 8 weeks
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.
Timed Instrumental Activities of Daily Living (TIADL) - Accuracy
Time frame: Change from Baseline in TIADL Accuracy assessed at 12 weeks (1 month post treatment)
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Ability Score
Time frame: Change from Baseline in MPAI-4 Ability Score assessed at 4 weeks
Assesses global outcome, including ability, adjustment and community participation indices.
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Ability Score
Time frame: Change from Baseline in MPAI-4 Ability Score assessed at 8 weeks
Assesses global outcome, including ability, adjustment and community participation indices.
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Ability Score
Time frame: Change from Baseline in MPAI-4 Ability Score assessed at 12 weeks (1 month post treatment)
Assesses global outcome, including ability, adjustment and community participation indices.
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Adjustment Score
Time frame: Change from Baseline in MPAI-4 Adjustment Score assessed at 4 weeks
Assesses global outcome, including ability, adjustment and community participation indices.
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Adjustment Score
Time frame: Change from Baseline in MPAI-4 Adjustment Score assessed at 8 weeks
Assesses global outcome, including ability, adjustment and community participation indices.
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Adjustment Score
Time frame: Change from Baseline in MPAI-4 Adjustment Score assessed at 12 weeks (1 month post treatment)
Assesses global outcome, including ability, adjustment and community participation indices.
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Participation Score
Time frame: Change from Baseline in MPAI-4 Participation Score assessed at 4 weeks
Assesses global outcome, including ability, adjustment and community participation indices.
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Participation Score
Time frame: Change from Baseline in MPAI-4 Participation Score assessed at 8 weeks
Assesses global outcome, including ability, adjustment and community participation indices.
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Participation Score
Time frame: Change from Baseline in MPAI-4 Participation Score assessed at 12 weeks (1 month post treatment)
Assesses global outcome, including ability, adjustment and community participation indices.
Timed Instrumental Activities of Daily Living (TIADL) - Reaction Time score
Time frame: Baseline (pretreatment) on TIADL - Reaction Time score
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.
Timed Instrumental Activities of Daily Living (TIADL) - Accuracy score
Time frame: Baseline (pretreatment) on TIADL - Accuracy score
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4)
Time frame: Baseline (pretreatment) MPAI-4 Adjustment score
Assesses global outcome, including ability, adjustment and community participation indices. The MPAI-4 is a 35-item questionnaire-based inventory that will be completed study staff and TBI survivors. It offers three subscales (Ability, Adjustment, and Participation) and has well-documented psychometric properties. MPAI-4 items represent the range of physical, cognitive, emotional, behavioral, and societal problems that TBI survivors often encounter; it also assess major obstacles to community integration.
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4)
Time frame: Baseline (pretreatment) MPAI-4 Participation score
Assesses global outcome, including ability, adjustment and community participation indices. The MPAI-4 is a 35-item questionnaire-based inventory that will be completed study staff and TBI survivors. It offers three subscales (Ability, Adjustment, and Participation) and has well-documented psychometric properties. MPAI-4 items represent the range of physical, cognitive, emotional, behavioral, and societal problems that TBI survivors often encounter; it also assess major obstacles to community integration.
Attention Network Test (ANT) Alerting Reaction Time score
Time frame: Change from Baseline in Altering Reaction Time Score assessed at 4 weeks
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Attention Network Test (ANT) Alerting Reaction Time score
Time frame: Change from Baseline in Altering Reaction Time Score assessed at 8 weeks
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Attention Network Test (ANT) Alerting Reaction Time score
Time frame: Change from Baseline in Altering Reaction Time Score assessed at 12 weeks (1 month post treatment)
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Attention Network Test (ANT) Orient Reaction Time score
Time frame: Baseline (pretreatment) Orienting Reaction Time score
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Attention Network Test (ANT) Orienting Reaction Time score
Time frame: Change from Baseline in Orienting Reaction Time Score assessed at 4 weeks
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Attention Network Test (ANT) Orienting Reaction Time score
Time frame: Change from Baseline in Orienting Reaction Time Score assessed at 8 weeks
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Attention Network Test (ANT) Orienting Reaction Time score
Time frame: Change from Baseline in Orienting Reaction Time Score assessed at 12 weeks (1 month post treatment)
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Attention Network Test (ANT) Executive-Control Reaction Time score
Time frame: Baseline (pretreatment) Executive-Control Reaction Time score
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Attention Network Test (ANT) Executive-Control Reaction Time score
Time frame: Change from Baseline in Executive-Control Reaction Time Score assessed at 4 weeks
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Attention Network Test (ANT) Executive-Control Reaction Time score
Time frame: Change from Baseline in Executive-Control Reaction Time Score assessed at 8 weeks
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Attention Network Test (ANT) Executive-Control Reaction Time score
Time frame: Change from Baseline in Executive-Control Reaction Time Score assessed at 12 weeks (1 month post treatment)
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Attention Network Test (ANT) Alerting Reaction Time score
Time frame: Baseline (pretreatment) Alerting Reaction Time score
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
ANT ERP (N1) Alerting Amplitude
Time frame: Baseline ANT ERP (N1) Alerting Amplitude assessed pretreatment
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
ANT ERP (N1) Alerting Amplitude
Time frame: Change from Baseline in ANT ERP (N1) Alerting Amplitude assessed at 4 weeks
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
ANT ERP (N1) Alerting Amplitude
Time frame: Change from Baseline in ANT ERP (N1) Alerting Amplitude assessed at 8 weeks
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
ANT ERP (N1) Alerting Amplitude
Time frame: Change from Baseline in ANT ERP (N1) Alerting Amplitude assessed at 12 weeks (1 month post treatment)
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
ANT ERP (N1) Orienting Amplitude
Time frame: Baseline ANT ERP (N1) Orienting Amplitude assessed pretreatment
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
ANT ERP (N1) Orienting Amplitude
Time frame: Change from Baseline in ANT ERP (N1) Orienting Amplitude assessed at 4 weeks
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
ANT ERP (N1) Orienting Amplitude
Time frame: Change from Baseline in ANT ERP (N1) Orienting Amplitude assessed at 8 weeks
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
ANT ERP (N1) Orienting Amplitude
Time frame: Change from Baseline in ANT ERP (N1) Orienting Amplitude assessed at 12 weeks (1 month post treatment)
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
ANT ERP (P3) Executive Amplitude
Time frame: Baseline ANT ERP (P3) Executive Amplitude assessed pretreatment
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
ANT ERP (P3) Executive Amplitude
Time frame: Baseline ANT ERP (P3) Executive Amplitude assessed at 4 weeks
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
ANT ERP (P3) Executive Amplitude
Time frame: Baseline ANT ERP (P3) Executive Amplitude assessed at 8 weeks
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
ANT ERP (P3) Executive Amplitude
Time frame: Baseline ANT ERP (P3) Executive Amplitude assessed at 12 weeks (1 month post treatment)
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Ability Score
Time frame: Baseline MPAI-4 Ability Score assessed pretreatment
Assesses global outcome, including ability, adjustment and community participation indices. The MPAI-4 is a 35-item questionnaire-based inventory that will be completed study staff and TBI survivors. It offers three subscales (Ability, Adjustment, and Participation) and has well-documented psychometric properties. MPAI-4 items represent the range of physical, cognitive, emotional, behavioral, and societal problems that TBI survivors often encounter; it also assess major obstacles to community integration.
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Adjustment Score
Time frame: Baseline MPAI-4 Adjustment Score assessed pretreatment
Assesses global outcome, including ability, adjustment and community participation indices. The MPAI-4 is a 35-item questionnaire-based inventory that will be completed study staff and TBI survivors. It offers three subscales (Ability, Adjustment, and Participation) and has well-documented psychometric properties. MPAI-4 items represent the range of physical, cognitive, emotional, behavioral, and societal problems that TBI survivors often encounter; it also assess major obstacles to community integration.
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Participation Score
Time frame: Baseline MPAI-4 Participation Score assessed pretreatment
Assesses global outcome, including ability, adjustment and community participation indices. The MPAI-4 is a 35-item questionnaire-based inventory that will be completed study staff and TBI survivors. It offers three subscales (Ability, Adjustment, and Participation) and has well-documented psychometric properties. MPAI-4 items represent the range of physical, cognitive, emotional, behavioral, and societal problems that TBI survivors often encounter; it also assess major obstacles to community integration.
8 secondary outcomes
Mindful Attention Awareness Scale-Lapses Only (MAAS-LO)
Time frame: Change from Baseline in MAAS-LO Score assessed at 4 weeks
Mindful Attention Awareness Scale-Lapses Only (MAAS-LO)
Time frame: Change from Baseline in MAAS-LO Score assessed at 8 weeks
Mindful Attention Awareness Scale-Lapses Only (MAAS-LO)
Time frame: Change from Baseline in MAAS-LO Score assessed at 12 weeks (1 month post treatment)
Satisfaction with Life Scale (SWLS)
Time frame: Baseline SWLS Score assessed pretreatment
Mindful Attention Awareness Scale-Lapses Only (MAAS-LO)
Time frame: Baseline (pretreatment) on MAAS-LO
Satisfaction with Life Scale (SWLS)
Time frame: Change from Baseline in SWLS Score assessed at 4 weeks
Satisfaction with Life Scale (SWLS)
Time frame: Change from Baseline in SWLS Score assessed at 8 weeks
Satisfaction with Life Scale (SWLS)
Time frame: Change from Baseline in SWLS Score assessed at 12 weeks (1 month post treatment)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William M Perlstein, PhD principal investigator
North Florida/South Georgia Veterans Health System, Gainesville, FL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct-attention training using web-based BrainHQ and Goal Management Training (GMT) in people with Brain Injuries, Traumatic, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Instrumental Activities of Daily Living (TIADL) (time frame: Baseline TIADL Reaction Time assessed pretreatment). The study lists 46 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.