Brain InjuryNCT01035606
Training in Goal-directed Attention Regulation for Individuals With Brain Injury
A study testing training in goal-directed attention regulation, brain health education and computer-assisted training in goal-directed attention regulation in people with Brain Injury, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Brain injuries affect the lives of numerous Veterans. This study examines how the brain is affected by injury and how rehabilitation training for attention dysfunction may change brain functioning. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Injury
- What is being tested?
- training in goal-directed attention regulation, brain health education and computer-assisted training in goal-directed attention regulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- history of traumatic brain injury
- greater than 1 week from injury
- residual dysfunction related to attention and executive control
Who cannot join
- aphasia
- active illicit drug use
- severe depression
- contraindications to MRI scanning
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Northern California Health Care System, Mather, CA
Sacramento, California, 95655
About this study
Official title: Plasticity in Brain Network to Enhance Cognitive Rehabilitation
Brain injuries affect the lives of numerous Veterans. This study examines how the brain is affected by injury and how rehabilitation training for attention dysfunction may change brain functioning.
Read the detailed description
Traumatic brain injuries (TBI) are a leading cause of long-term disability among combat Veterans. The most common and persistent sequelae after TBI are cognitive-behavioral deficits in 'executive control' and 'attention' functions. Such abnormalities may directly contribute to poor long-term outcomes as well as impede rehabilitation of dysfunction in other cognitive and motor domains. Effective treatments would potentially make a major impact in improving functional outcomes, but consistently effective treatments are not available. The overall goal of this research is to improve the investigators' understanding of plasticity in brain function after TBI and to develop improved cognitive neurorehabilitation treatments. The intervention involves individual and group-based training in cognitive skills.
- Conditions
- Brain Injury
- Being tested
- training in goal-directed attention regulation, brain health education, computer-assisted training in goal-directed attention regulation
- Keywords
- attention, rehabilitation, training, functional MRI, executive function, brain injury
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
training in goal-directed attention regulationBehavioural
training in goal-directed attention regulation
brain health educationBehavioural
brain health education workshops
computer-assisted training in goal-directed attention regulationBehavioural
computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills
| Study group | Role | What they receive |
|---|---|---|
| Goal-oriented Attention Regulation Training | Experimental | training in goal-directed attention regulation Receives: Behavioral: training in goal-directed attention regulation |
| Education | Active comparator | brain health education Receives: Behavioral: brain health education |
| Technology-assisted Goal-directed Self-Regulation Training | Experimental | computer-assisted training in goal-directed attention regulation Receives: Behavioral: computer-assisted training in goal-directed attention regulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-report
Responses to goal processing questionnaire relating to areas of personal goal-based functioning. This scale measured participants self-perceived changes to their cognitive and emotional functioning. Participants indicated the degree to which they perceived changes to 11 questions after receiving trainings in Arm 1 and Arm 3 on a 10-point scale (1=domain became worse, 5 = no change, 10 = domain improved). Participants did not complete this measure after Arm 2.
Measured: 5 Weeks (After completion of active trainings in Arm 1 and Arm 3)
Secondary outcomes (2)
Change From Baseline to Post-training for Task Errors on a Functional Performance Measure
Participants completed a functional assessment task, the modified Multiple Errands Task (MET). The MET is an unstructured functional task that permits assessment of participants' abilities to follow outlined rules and complete multiple 'real-world' tasks in a limited time period. Participants were provided written instructions and a map of the hospital where the assessment took place, and were instructed to complete 12 subtasks in 40 minutes while following 9 specified rules. Participants completed this at task at baseline and following Training (Arms 1 \& 2, but not 3). Outcome measure was computed as post-training - baseline (negative value reflects less errors made post-training).
Measured: 5 weeks (After completion of Arm 1 and Arm 2)
Change to Attention and Executive Functioning Composite Scores
Participants completed the following neuropsychological measures of attention and executive functions before and after Arms 1 and 2, but not Arm 3.
Letter Number Sequencing from WIAT-III; Auditory Consonant Trigram: 9,18, 36 seconds; Digit Vigilance Test (Time and Errors); DKEFS subtests: Design Fluency, Verbal Fluency Switching, Inhibition (Time and Errors); and Inhibition/Switching (Time and Errors); and Trails B. Performance on these measures were scored based upon age, and when available, educational and repeated administration norms. Resultant scores were transformed into z-scores and aggregated to form a composite measure. Higher z-scores reflect better functioning.
The unit of analysis for this outcome was the change score from baseline to post-training. Positive change scores reflect improved performance over time[post-training - baseline], whereas negative change scores reflect worsening performance over time.
Measured: 5 weeks (After completion of Arm 1 and Arm 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2015
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain InjuryStudies 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
- Parallel groups
- Model description
- The design for Arms 1 and 2 was a cross-over design. Half the participants completed Arm 1 first and then crossed-over to Arm 2; the remaining half completed Arm 2 first and then crossed-over to Arm 1. Thus, all participants completed both Arm 1 and 2. Arm 3 represented a parallel study. Participants enrolled in this arm did not cross-over to any other condition.
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Mark D'Esposito, MD, Principal investigator, VA Northern California Health Care System, Mather, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01035606
- Sponsor's protocol ID
- B4605-I
- Status last verified
- Oct 2017
- First submitted
- 16 Dec 2009
- Last updated
- 20 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Novakovic-Agopian T, Chen AJ, Rome S, Abrams G, Castelli H, Rossi A, McKim R, Hills N, D'Esposito M. Rehabilitation of executive functioning with training in attention regulation applied to individually defined goals: a pilot study bridging theory, assessment, and treatment. J Head Trauma Rehabil. 2011 Sep-Oct;26(5):325-38. doi: 10.1097/HTR.0b013e3181f1ead2.
PubMed 21169860Chen AJ, Novakovic-Agopian T, Nycum TJ, Song S, Turner GR, Hills NK, Rome S, Abrams GM, D'Esposito M. Training of goal-directed attention regulation enhances control over neural processing for individuals with brain injury. Brain. 2011 May;134(Pt 5):1541-54. doi: 10.1093/brain/awr067. Epub 2011 Apr 22.
PubMed 21515904
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasticity in Brain Network to Enhance Cognitive Rehabilitation
- ClinicalTrials.gov ID
- NCT01035606
- Acronym / sponsor ID
- B4605-I
- Conditions
- Brain Injury
- Keywords
- attention, rehabilitation, training, functional MRI, executive function, brain injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of California, San Francisco
- Study start
- Sep 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 18 Dec 2009 (estimated)
- Results
- Posted 20 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brain injuries affect the lives of numerous Veterans. This study examines how the brain is affected by injury and how rehabilitation training for attention dysfunction may change brain functioning.
Detailed description
Traumatic brain injuries (TBI) are a leading cause of long-term disability among combat Veterans. The most common and persistent sequelae after TBI are cognitive-behavioral deficits in 'executive control' and 'attention' functions. Such abnormalities may directly contribute to poor long-term outcomes as well as impede rehabilitation of dysfunction in other cognitive and motor domains. Effective treatments would potentially make a major impact in improving functional outcomes, but consistently effective treatments are not available. The overall goal of this research is to improve the investigators' understanding of plasticity in brain function after TBI and to develop improved cognitive neurorehabilitation treatments. The intervention involves individual and group-based training in cognitive skills.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The design for Arms 1 and 2 was a cross-over design. Half the participants completed Arm 1 first and then crossed-over to Arm 2; the remaining half completed Arm 2 first and then crossed-over to Arm 1. Thus, all participants completed both Arm 1 and 2. Arm 3 represented a parallel study. Participants enrolled in this arm did not cross-over to any other condition.
| Arm | Type | Receives |
|---|---|---|
| Goal-oriented Attention Regulation Training | Experimental | Behavioral: training in goal-directed attention regulationtraining in goal-directed attention regulation |
| Education | Active comparator | Behavioral: brain health educationbrain health education |
| Technology-assisted Goal-directed Self-Regulation Training | Experimental | Behavioral: computer-assisted training in goal-directed attention regulationcomputer-assisted training in goal-directed attention regulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- history of traumatic brain injury
- greater than 1 week from injury
- residual dysfunction related to attention and executive control
Key exclusion criteria (4 listed)
- aphasia
- active illicit drug use
- severe depression
- contraindications to MRI scanning
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 |
|---|---|---|
| training in goal-directed attention regulationtraining in goal-directed attention regulation | Behavioural | Goal-oriented Attention Regulation Training |
| brain health educationbrain health education workshops | Behavioural | Education |
| computer-assisted training in goal-directed attention regulationcomputer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills | Behavioural | Technology-assisted Goal-directed Self-Regulation Training |
Primary outcome
Self-report
Time frame: 5 Weeks (After completion of active trainings in Arm 1 and Arm 3)
Responses to goal processing questionnaire relating to areas of personal goal-based functioning. This scale measured participants self-perceived changes to their cognitive and emotional functioning. Participants indicated the degree to which they perceived changes to 11 questions after receiving trainings in Arm 1 and Arm 3 on a 10-point scale (1=domain became worse, 5 = no change, 10 = domain improved). Participants did not complete this measure after Arm 2.
2 secondary outcomes
Change From Baseline to Post-training for Task Errors on a Functional Performance Measure
Time frame: 5 weeks (After completion of Arm 1 and Arm 2)
Change to Attention and Executive Functioning Composite Scores
Time frame: 5 weeks (After completion of Arm 1 and Arm 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21169860Novakovic-Agopian T, Chen AJ, Rome S, Abrams G, Castelli H, Rossi A, McKim R, Hills N, D'Esposito M. Rehabilitation of executive functioning with training in attention regulation applied to individually defined goals: a pilot study bridging theory, assessment, and treatment. J Head Trauma Rehabil. 2011 Sep-Oct;26(5):325-38. doi: 10.1097/HTR.0b013e3181f1ead2.
- Results publication: PubMed 21515904Chen AJ, Novakovic-Agopian T, Nycum TJ, Song S, Turner GR, Hills NK, Rome S, Abrams GM, D'Esposito M. Training of goal-directed attention regulation enhances control over neural processing for individuals with brain injury. Brain. 2011 May;134(Pt 5):1541-54. doi: 10.1093/brain/awr067. Epub 2011 Apr 22.
- Northern California Institute for Research and EducationLink provided by the sponsor.
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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.
Mark D'Esposito, MD principal investigator
VA Northern California Health Care System, Mather, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing training in goal-directed attention regulation, brain health education and computer-assisted training in goal-directed attention regulation in people with Brain Injury, 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 20 Oct 2017. 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?
Yes. Results are posted in the registry (first posted 20 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self-report (time frame: 5 Weeks (After completion of active trainings in Arm 1 and Arm 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01035606, which also lists 2 linked publications.
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 20 Oct 2017.