Traumatic Brain InjuryDPSVMNCT02310633
Developing Process-Specific Verbal Memory Interventions for Veterans With Tramatic Brain Injury (TBI)
A study testing Memory Strategy Training, Errorless Learning and Retrieval Practice in people with Traumatic Brain Injury, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Blast-related and blunt traumatic brain injury is a key priority area of Rehabilitation Research \& Development (RR\&D) and represents a critically important public health problem facing the Veteran population. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Memory Strategy Training, Errorless Learning and Retrieval Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2015to 29 Dec 2017
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veterans aged 25-65 who are post-deployment,
- having served in Operation Iraqi Freedom (OIF), Operation Enduring Freedom (OEF), or Operation New Dawn (OND),
- who meet criteria for moderate or severe TBI during deployment,
- are eligible to participate.
- Patients will meet the 2007 VA/DoD criteria54,
- supplemented by data from the VA TBI Identification Semi-Structured Interview55.
Show all 12Show fewer
- All patients will have gone through Level I and II assessments with positive findings.
- Primary inclusion criteria:
- Moderate to Severe Traumatic Brain Injury (M-STBI) (blast and blunt),
- > 6 months post-injury,
- no receptive aphasia (impairing ability to comprehend task instructions),
- able to participate in return visits.
Who cannot join
- Primary exclusion criteria:
- No MRI contraindications,
- not claustrophobic,
- no current or past history of disabling Axis I psychiatric disorders (except for PTSD and depression),
- no active substance abuse,
- not pregnant.
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: Developing Process-Specific Verbal Memory Interventions for Veterans With TBI
Blast-related and blunt traumatic brain injury is a key priority area of Rehabilitation Research \& Development (RR\&D) and represents a critically important public health problem facing the Veteran population. Developing efficacious treatments for persistent memory deficits seen in this population is a key step in reducing the impact that such problems have in the everyday lives of Veterans. Memory problems after TBI in Veterans are quite heterogeneous, and efficacy will likely be maximized by developing and disseminating multiple alternative treatments individually matched to the Veteran's key deficits, and by research that seeks to understand the cognitive and neural basis of treatment-related change over time. The results of this approach may aid clinical decision making and assignment of patients to rehabilitative treatments most likely to improve memory capacity and functional outcome.
Read the detailed description
Memory dysfunction can result from impairments along a continuum of information processing, from poor initial acquisition of information during learning to disturbed retrieval of stored memory when it is later needed to perform a task1. The heterogeneous nature of TBI-related memory impairment is well-known, and there is a critical need to better understand such disease heterogeneity in order to enhance diagnosis and therapeutic management2. Several subtypes of memory dysfunction after TBI have been identified3,4. First, some TBI survivors exhibit impaired memory acquisition/encoding (e.g., frontal system damage)5. Second, some exhibit impaired memory consolidation/storage impairment (e.g., prominent damage to temporal lobe systems6). Third, some show impairment in retrieval of information5,7. This heterogeneity results from the variable nature and severity of underlying brain trauma resulting from unpredictable mechanical forces2,8.
It has been suggested that parsing this underlying variability should take precedence over generalities regarding the effect of TBI on memory when conceptualizing or treating memory disorders in this population8 Nevertheless, many rehabilitation programs utilize a "one size fits all" approach to memory training, based (typically) on training compensatory strategies, with no training specifically targeted to the identifiable component processes of memory that could be differentially impaired (encoding, consolidation/storage, and retrieval), and which might respond differentially to more specifically targeted treatment. This situation in clinical practice is due to the lack of evidence upon which to base informed decision-making in allocating specifically targeted memory re-training for individual survivors of TBI, based on clinical test results identifying which memory component processes are impaired (encoding, consolidation/storage, and retrieval). Because of this, there is little attempt to appropriately match patient impairment to targeted treatments.
There are existing training protocols for training these three components of memory processing, as follows: encoding (memory strategy training9), consolidation (errorless learning10), and retrieval (retrieval practice11, but their efficacy has not been tested in TBI survivors with documented impairments in each component. That is, to the investigators' knowledge, there is no solid evidence for memory training in TBI survivors that supports the widely held belief that specifically matching the patient impairment to the treatment leads to better treatment outcomes. This proposal attempts to fill this gap in the investigators' knowledge. Prior to testing the efficacy of these three types of training in a large trial, it is important to make standard preparations, such as refining and testing training materials and ensuring fidelity of treatment methods across clinicians.
Aim 1. Aim 1 is to refine and validate three separate, process-specific memory rehabilitation treatments that focus on improving information-processing at the encoding, consolidation, or retrieval stage for Veterans with chronic moderate/severe TBI.
Objective 1.1. Generate treatment manuals for three process-specific memory treatments.
Objective 1.2. Test and refine treatment fidelity so that each of the three interventions can be reliably delivered by different clinicians.
Aim 2. Aim 2 is to provide a preliminary test of the response to the three memory interventions. At baseline, TBI survivors will be evaluated for memory function in each of these three memory component processes using established neuropsychometric methods. Their experimental treatment allocation will be to the treatment targeting their most impaired memory component. In addition, each subject will serve as his/her own control, by engaging in a treatment targeted to another memory component ('mismatched' group).
Hypothesis A. Matched vs. mismatched group will show differential improvement in memory component function, with the former group benefitting to a significantly greater degree. (Primary measures: Memory component performance, encoding, consolidation, retrieval; secondary: cognitive function and quality of life).
Aim 3. Aim 3 is to establish links between the behavioral taxonomy of the three memory components and differences in brain structure and function documented with diffusion tensor imaging and functional connectivity analysis. This is a key first step in establishing brain-based metrics of neuroplastic change after memory therapy in the investigators' research program.
Objective 3.1. Identify specific and unique imaging signatures that distinguish patients with deficits in encoding, consolidation, and retrieval, respectively. Primary measures: structural measures of morphometry and white matter integrity (FA) and functional connectivity (cross correlation and total interdependence) in identified brain networks damaged in TBI.
Clinical Implications. This research has the potential to devise a method to match specific subcomponents of memory impairment to specifically targeted memory interventions, thus maximizing recovery of memory and function. The results of this investigation will be used to refine the interventions, to evaluate cognitive and functional endpoints, and to power a larger clinical trial that will yield data enabling clinicians to match TBI patients to effective treatments based on their individual profile of memory dysfunction.
- Conditions
- Traumatic Brain Injury
- Being tested
- Memory Strategy Training, Errorless Learning, Retrieval Practice
- Keywords
- TBI, memory disorder, injury, brain, traumatic, rehabilitation
- Medical subject headings
- Brain Injuries, Traumatic, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memory Strategy TrainingBehavioural
This intervention involves intervention that teaches participants to use active encoding strategies to learn and remember new information. The intervention will be implemented using verbal and face-name paired associate learning.
Errorless LearningBehavioural
This intervention enhances consolidation of correct target information by preventing false recall of incorrect information during the acquisition phase. Participants are encouraged to recall target information only if they are sure it is correct, thus eliminating errors. The intervention will be implemented using verbal and face-name paired associate learning.
Retrieval PracticeBehavioural
This intervention enhances retrieval of correct target information by actively practicing retrieval in the presence of a cue. The intervention will be implemented using verbal and face-name paired associate learning.
| Study group | Role | What they receive |
|---|---|---|
| Memory Strategy Training | Active comparator | This arm involves intervention that teaches participants to use active encoding strategies to learn and remember new information. Receives: Behavioral: Memory Strategy Training |
| Errorless Learning | Active comparator | This arm involves intervention that enhances consolidation of correct target information by preventing false recall of incorrect information during the acquisition phase. Receives: Behavioral: Errorless Learning |
| Retrieval Practice | Active comparator | This arm involves intervention that enhances retrieval of correct target information by actively practicing retrieval in the presence of a cue. Receives: Behavioral: Retrieval Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in performance on paired-associate learning of words and face-name pairs
Participants will be tested each session on paired-associate learning (words and face-name pairs) for trained and untrained items
Measured: At the end of each session (twice weekly), up to 12 weeks
Change in functional brain connectivity within memory-relevant brain networks
Participants will undergo MRI scanning before and after memory interventions to assess the effect of intervention on functional brain connectivity in default mode network (DMN), task-positive network (TPN), and salience network (SN)
Measured: Prior to start of intervention (Week 0) and again at the end of intervention (Week 8)
Secondary outcomes (7)
Mayo-Portland Adaptability Inventory (MPAI-4)
This measure assesses the overall impact of TBI on functional capacity
Measured: Week 0, Week 8, and 1 month after treatment is concluded (Week 12)
RAVLT
This is an independent measure of list learning designed to assess the effect of memory intervention on learning of untrained items.
Measured: Week 0, Week 8, and 1 month after treatment is concluded (Week 12)
Brief Visuo-Spatial Learning Test-Revised (BVLT-R)
This is a measure of nonverbal memory (drawing from memory), designed to assess the effect of memory intervention on learning and memory for untrained items.
Measured: Week 0, Week 8, and 1 month after treatment is concluded (Week 12)
Ecologically Oriented Neurorehabilitation of Memory (EON-MEM) Everyday Memory Simulations
These are tasks of everyday memory designed to assess whether effects of memory intervention generalize to real-world memory tasks.
Measured: Week 0, Week 8, and 1 month after treatment is concluded (Week 12)
Quality of Life after Brain Injury (QOLIBRI)
This is a quality of life measure after brain injury, designed to assess whether effects of memory intervention extend to quality of life.
Measured: Week 0, Week 8, and 1 month after treatment is concluded (Week 12)
PROMIS and Neuro-QOL Item Banks
These items assess outcome from the patient perspective (patient-reported outcomes)
Measured: Week 0, Week 8, and 1 month after treatment is concluded (Week 12)
Satisfaction with Life Scale (SWLS)
This questionnaire assesses overall life quality and satisfaction.
Measured: Week 0, Week 8, and 1 month after treatment is concluded (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study start5 Jan 2015
- Primary completion22 Dec 2017
- Study completion29 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Florida
- Responsible party
- Sponsor
- Investigators
- Russell M Bauer, PhD, Principal investigator, North Florida/South Georgia Veterans Health System, Gainesville, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310633
- Sponsor's protocol ID
- N1730-P
- Other IDs
- 1I21RX001730-01
- Acronym
- DPSVM
- Status last verified
- Oct 2024
- First submitted
- 19 Nov 2014
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available to other researchers in a de-identified, password protected file.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Process-Specific Verbal Memory Interventions for Veterans With TBI
- ClinicalTrials.gov ID
- NCT02310633
- Acronym / sponsor ID
- DPSVM / N1730-P
- Conditions
- Traumatic Brain Injury
- Keywords
- TBI, memory disorder, injury, brain, traumatic, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Florida
- Study start
- 5 Jan 2015 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 29 Dec 2017 (actual)
- First posted
- 8 Dec 2014 (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.
Blast-related and blunt traumatic brain injury is a key priority area of Rehabilitation Research \& Development (RR\&D) and represents a critically important public health problem facing the Veteran population. Developing efficacious treatments for persistent memory deficits seen in this population is a key step in reducing the impact that such problems have in the everyday lives of Veterans. Memory problems after TBI in Veterans are quite heterogeneous, and efficacy will likely be maximized by developing and disseminating multiple alternative treatments individually matched to the Veteran's key deficits, and by research that seeks to understand the cognitive and neural basis of treatment-related change over time. The results of this approach may aid clinical decision making and assignment of patients to rehabilitative treatments most likely to improve memory capacity and functional outcome.
Detailed description
Memory dysfunction can result from impairments along a continuum of information processing, from poor initial acquisition of information during learning to disturbed retrieval of stored memory when it is later needed to perform a task1. The heterogeneous nature of TBI-related memory impairment is well-known, and there is a critical need to better understand such disease heterogeneity in order to enhance diagnosis and therapeutic management2. Several subtypes of memory dysfunction after TBI have been identified3,4. First, some TBI survivors exhibit impaired memory acquisition/encoding (e.g., frontal system damage)5. Second, some exhibit impaired memory consolidation/storage impairment (e.g., prominent damage to temporal lobe systems6). Third, some show impairment in retrieval of information5,7. This heterogeneity results from the variable nature and severity of underlying brain trauma resulting from unpredictable mechanical forces2,8.
It has been suggested that parsing this underlying variability should take precedence over generalities regarding the effect of TBI on memory when conceptualizing or treating memory disorders in this population8 Nevertheless, many rehabilitation programs utilize a "one size fits all" approach to memory training, based (typically) on training compensatory strategies, with no training specifically targeted to the identifiable component processes of memory that could be differentially impaired (encoding, consolidation/storage, and retrieval), and which might respond differentially to more specifically targeted treatment. This situation in clinical practice is due to the lack of evidence upon which to base informed decision-making in allocating specifically targeted memory re-training for individual survivors of TBI, based on clinical test results identifying which memory component processes are impaired (encoding, consolidation/storage, and retrieval). Because of this, there is little attempt to appropriately match patient impairment to targeted treatments.
There are existing training protocols for training these three components of memory processing, as follows: encoding (memory strategy training9), consolidation (errorless learning10), and retrieval (retrieval practice11, but their efficacy has not been tested in TBI survivors with documented impairments in each component. That is, to the investigators' knowledge, there is no solid evidence for memory training in TBI survivors that supports the widely held belief that specifically matching the patient impairment to the treatment leads to better treatment outcomes. This proposal attempts to fill this gap in the investigators' knowledge. Prior to testing the efficacy of these three types of training in a large trial, it is important to make standard preparations, such as refining and testing training materials and ensuring fidelity of treatment methods across clinicians.
Aim 1. Aim 1 is to refine and validate three separate, process-specific memory rehabilitation treatments that focus on improving information-processing at the encoding, consolidation, or retrieval stage for Veterans with chronic moderate/severe TBI.
Objective 1.1. Generate treatment manuals for three process-specific memory treatments.
Objective 1.2. Test and refine treatment fidelity so that each of the three interventions can be reliably delivered by different clinicians.
Aim 2. Aim 2 is to provide a preliminary test of the response to the three memory interventions. At baseline, TBI survivors will be evaluated for memory function in each of these three memory component processes using established neuropsychometric methods. Their experimental treatment allocation will be to the treatment targeting their most impaired memory component. In addition, each subject will serve as his/her own control, by engaging in a treatment targeted to another memory component ('mismatched' group).
Hypothesis A. Matched vs. mismatched group will show differential improvement in memory component function, with the former group benefitting to a significantly greater degree. (Primary measures: Memory component performance, encoding, consolidation, retrieval; secondary: cognitive function and quality of life).
Aim 3. Aim 3 is to establish links between the behavioral taxonomy of the three memory components and differences in brain structure and function documented with diffusion tensor imaging and functional connectivity analysis. This is a key first step in establishing brain-based metrics of neuroplastic change after memory therapy in the investigators' research program.
Objective 3.1. Identify specific and unique imaging signatures that distinguish patients with deficits in encoding, consolidation, and retrieval, respectively. Primary measures: structural measures of morphometry and white matter integrity (FA) and functional connectivity (cross correlation and total interdependence) in identified brain networks damaged in TBI.
Clinical Implications. This research has the potential to devise a method to match specific subcomponents of memory impairment to specifically targeted memory interventions, thus maximizing recovery of memory and function. The results of this investigation will be used to refine the interventions, to evaluate cognitive and functional endpoints, and to power a larger clinical trial that will yield data enabling clinicians to match TBI patients to effective treatments based on their individual profile of memory dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Memory Strategy Training | Active comparator | Behavioral: Memory Strategy TrainingThis arm involves intervention that teaches participants to use active encoding strategies to learn and remember new information. |
| Errorless Learning | Active comparator | Behavioral: Errorless LearningThis arm involves intervention that enhances consolidation of correct target information by preventing false recall of incorrect information during the acquisition phase. |
| Retrieval Practice | Active comparator | Behavioral: Retrieval PracticeThis arm involves intervention that enhances retrieval of correct target information by actively practicing retrieval in the presence of a cue. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Veterans aged 25-65 who are post-deployment,
- having served in Operation Iraqi Freedom (OIF), Operation Enduring Freedom (OEF), or Operation New Dawn (OND),
- who meet criteria for moderate or severe TBI during deployment,
- are eligible to participate.
- Patients will meet the 2007 VA/DoD criteria54,
Key exclusion criteria (6 listed)
- Primary exclusion criteria:
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 |
|---|---|---|
| Memory Strategy TrainingThis intervention involves intervention that teaches participants to use active encoding strategies to learn and remember new information. The intervention will be implemented using verbal and face-name paired associate learning. | Behavioural | Memory Strategy Training |
| Errorless LearningThis intervention enhances consolidation of correct target information by preventing false recall of incorrect information during the acquisition phase. Participants are encouraged to recall target information only if they are sure it is correct, thus eliminating errors. The intervention will be implemented using verbal and face-name paired associate learning. | Behavioural | Errorless Learning |
| Retrieval PracticeThis intervention enhances retrieval of correct target information by actively practicing retrieval in the presence of a cue. The intervention will be implemented using verbal and face-name paired associate learning. | Behavioural | Retrieval Practice |
Primary outcome
Change in performance on paired-associate learning of words and face-name pairs
Time frame: At the end of each session (twice weekly), up to 12 weeks
Participants will be tested each session on paired-associate learning (words and face-name pairs) for trained and untrained items
Change in functional brain connectivity within memory-relevant brain networks
Time frame: Prior to start of intervention (Week 0) and again at the end of intervention (Week 8)
Participants will undergo MRI scanning before and after memory interventions to assess the effect of intervention on functional brain connectivity in default mode network (DMN), task-positive network (TPN), and salience network (SN)
7 secondary outcomes
Mayo-Portland Adaptability Inventory (MPAI-4)
Time frame: Week 0, Week 8, and 1 month after treatment is concluded (Week 12)
RAVLT
Time frame: Week 0, Week 8, and 1 month after treatment is concluded (Week 12)
Brief Visuo-Spatial Learning Test-Revised (BVLT-R)
Time frame: Week 0, Week 8, and 1 month after treatment is concluded (Week 12)
Ecologically Oriented Neurorehabilitation of Memory (EON-MEM) Everyday Memory Simulations
Time frame: Week 0, Week 8, and 1 month after treatment is concluded (Week 12)
Quality of Life after Brain Injury (QOLIBRI)
Time frame: Week 0, Week 8, and 1 month after treatment is concluded (Week 12)
PROMIS and Neuro-QOL Item Banks
Time frame: Week 0, Week 8, and 1 month after treatment is concluded (Week 12)
Satisfaction with Life Scale (SWLS)
Time frame: Week 0, Week 8, and 1 month after treatment is concluded (Week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Home page for the Gainesville VA Brain Rehabilitation Research Center of ExcellenceLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be available to other researchers in a de-identified, password protected file.
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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.
Russell M Bauer, 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 Memory Strategy Training, Errorless Learning and Retrieval Practice in people with Traumatic 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 12 inclusion and 6 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 1 Nov 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in performance on paired-associate learning of words and face-name pairs (time frame: At the end of each session (twice weekly), up to 12 weeks). The study lists 2 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 1 Nov 2024.