Mild Traumatic Brain InjuryVoCET-mTBINCT04245124
Validation of Cognitive Enhancement Techniques for Mild Traumatic Brain Injury
A study testing Strategic Memory Advanced Reasoning Training and Traditional Cognitive Rehabilitation in people with Mild Traumatic Brain Injury, run by The Defense and Veterans Brain Injury Center at 1 site in United States.
Trial summary
With an average of 21,000 diagnosed brain injuries each year among military personnel, traumatic brain injury (TBI) remains a major health concern for the United States Military Health System. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- Strategic Memory Advanced Reasoning Training and Traditional Cognitive Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 30 Sep 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- • Male or female ages 18 years or older
- Active duty military personnel
- History of mTBI: participants will have a history of at least one mTBI sustained >3 months previously based on criteria of the DoD diagnostic criteria (Department of Veterans Affairs and Department of Defense, 2016). This specifies an external force to the head which resulted in physiological dysfunction of the brain as manifested by one or more of the following acute symptoms:
- Any loss of consciousness (not to exceed 30 minutes)
- Any loss of memory for the events immediately before or after the injury (not to exceed 1 day)
- Any alteration of consciousness or change in mental state (not to exceed 24 hours)
- Persistent Post-Concussive Symptoms: Participants will endorse elevated neurobehavioral symptomatology compared to published normative data (Soble et al. 2014), with at least one cognitive symptom (e.g., a score of 3 or greater on at least one of the four items on the NSI cognitive domain).
Who cannot join
- • History of TBI (any severity) within 3 months of enrollment.
- History of moderate, severe, or penetrating TBI as defined by DOD/VA guidelines during their lifetime
- Current substance use disorder based on patient self-report.
- History of a neurological disease other than mild TBI such as multiple sclerosis, cerebral vascular accident, brain tumor, neurodegenerative disease, or neuro-motor disorder.
- Current, active suicidal or homicidal ideation.
- Impaired decision-making capacity.
Trial locations and contacts
1 site in 1 country.
MELISSA JENSEN contact
United States1 site, 1 recruiting
- Recruiting
Naval Hospital Camp Pendleton
Oceanside, California, 92055
Angela Basham, Angela.g.basham.ctr@mail.mil
About this study
With an average of 21,000 diagnosed brain injuries each year among military personnel, traumatic brain injury (TBI) remains a major health concern for the United States Military Health System. Mild traumatic brain injury (mTBI) is the most common type of brain injury sustained by military personnel and may result in chronic cognitive impairment.Unfortunately, many service members (SMs) have a history of multiple head injuries as well as psychological co-morbidities that negatively influence recovery. Advances in treatment options for cognitive rehabilitation following mTBI have been of increasing interest to the medical community and may increase treatment efficacy for injured SMs to ensure force readiness.
Cognitive Rehabilitation (CR) for severe brain injury focuses on compensatory strategies for activities of daily living such as using lists to remember grocery items or reminders to take medications and attend medical appointments. Research has shown CR interventions to have considerable effectiveness in the acute and sub-acute phase of recovery after severe TBI. But there is insufficient evidence that they improve rates of individuals returning to work, independence in activities of daily living (ADL), community re-integration, or quality of life.
Read the detailed description
Cognitive Rehabilitation for mild brain injury has shown some modest evidence of effectiveness. CR interventions for mTBI typically focus on compensating for subjective and functional cognitive complaints. A number of recent studies have examined the use of compensatory CR approaches for individuals (primarily military veterans) diagnosed with mild cognitive impairment from a likely mTBI. These interventions taught individuals adaptive functional skills (e.g., cognitive mnemonics) and highlighted use of external aids such as smart phone scheduling/reminder applications. A randomized control trial that included 16 veterans with TBI (mixed mild and moderate severity), found this compensatory CR intervention was effective at reducing overall symptoms, but did not impact cognitive performance or work-outcomes. In a secondary study, there was some evidence that the compensatory CR intervention improved memory at 6 months post-treatment and quality of life at 12 months but there was not a consistent pattern of improvement compared to controls.
Generalizability from civilian and veteran communities to active duty SMs may pose some unique and unexplored factors as the goal of treatment is not remediation of common activities of daily living (e.g., remembering appointments) but in contrast, the goal is military readiness needed for worldwide deployability to potential wartime environments (e.g., "cognitive readiness").
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- Strategic Memory Advanced Reasoning Training, Traditional Cognitive Rehabilitation
- Keywords
- COGNITIVE REHABILITATION
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strategic Memory Advanced Reasoning TrainingOther
SMART focuses on three metacognitive strategies: Strategic Attention, Integrated Reasoning and Innovation.
Traditional Cognitive RehabilitationOther
Participants randomized to the TCR condition will participate in a clinician-directed intervention that provides manualized, traditional clinician-directed cognitive rehabilitation that was developed for the SCORE trial (Cooper et al., 2017)
| Study group | Role | What they receive |
|---|---|---|
| SMART INTERVENTION | Experimental | N= 81 20 HOURS THERAPY IMMEDIATE POST TREATMENT EVALUATION 3 MONTH POST TREATMENT EVALUATION Receives: Other: Strategic Memory Advanced Reasoning Training |
| TCR | Experimental | N= 81 60 HOURS THERAPY IMMEDIATE POST TREATMENT EVALUATION 3 MONTH POST TREATMENT EVALUATION Receives: Other: Traditional Cognitive Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive impairment
Cognitive impairment will be measured using the Global Deficit Score (GDS) which allows for the detection of subtle and varied degree of impairment from multiple measures.
Measured: 4 MONTHS
Secondary outcomes (2)
Change in healthcare utilization
Healthcare utilization post-treatment, as measured by the number of medical appointments to rehabilitation specialists.
Measured: 4.5 MONTHS
Change in level of occupational performance
Ratings of occupational performance by a direct supervisor using a modified Checklist of Military Activities of Daily Living (M-ADL).
Measured: 4.5 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 Feb 2021 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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
- Primary Aim: Difference in Cognitive and Neurophysiological Function between SMART and TCR. Multilevel mixed-effect modeling will be conducted for Aim 1 with treatment modality (SMART vs. TCR) as the independent variable. This approach will take into consideration between-subject variance based on randomized group, as well as within-subject variance for repeated measures. Primary analyses will be based on intention to treat, and we will leverage the statistical power of multilevel modeling to handle missing follow-up data. Outcome will be assessed as change in GDS over time. A significant p-value of 0.05 will be used to assess the main effects.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Defense and Veterans Brain Injury Center
- Sponsor type
- US federal agency
- Collaborators
- The University of Texas at Dallas
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245124
- Sponsor's protocol ID
- NHCP.2020.0006
- Acronym
- VoCET-mTBI
- Status last verified
- Feb 2021
- First submitted
- 8 Nov 2019
- Last updated
- 3 Feb 2021
- Results posted
- 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 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Cognitive Enhancement Techniques for Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT04245124
- Acronym / sponsor ID
- VoCET-mTBI / NHCP.2020.0006
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- COGNITIVE REHABILITATION
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- The Defense and Veterans Brain Injury CenterUS federal agency
- Collaborators
- The University of Texas at Dallas
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 28 Jan 2020 (actual)
- 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.
With an average of 21,000 diagnosed brain injuries each year among military personnel, traumatic brain injury (TBI) remains a major health concern for the United States Military Health System. Mild traumatic brain injury (mTBI) is the most common type of brain injury sustained by military personnel and may result in chronic cognitive impairment.Unfortunately, many service members (SMs) have a history of multiple head injuries as well as psychological co-morbidities that negatively influence recovery. Advances in treatment options for cognitive rehabilitation following mTBI have been of increasing interest to the medical community and may increase treatment efficacy for injured SMs to ensure force readiness.
Cognitive Rehabilitation (CR) for severe brain injury focuses on compensatory strategies for activities of daily living such as using lists to remember grocery items or reminders to take medications and attend medical appointments. Research has shown CR interventions to have considerable effectiveness in the acute and sub-acute phase of recovery after severe TBI. But there is insufficient evidence that they improve rates of individuals returning to work, independence in activities of daily living (ADL), community re-integration, or quality of life.
Detailed description
Cognitive Rehabilitation for mild brain injury has shown some modest evidence of effectiveness. CR interventions for mTBI typically focus on compensating for subjective and functional cognitive complaints. A number of recent studies have examined the use of compensatory CR approaches for individuals (primarily military veterans) diagnosed with mild cognitive impairment from a likely mTBI. These interventions taught individuals adaptive functional skills (e.g., cognitive mnemonics) and highlighted use of external aids such as smart phone scheduling/reminder applications. A randomized control trial that included 16 veterans with TBI (mixed mild and moderate severity), found this compensatory CR intervention was effective at reducing overall symptoms, but did not impact cognitive performance or work-outcomes. In a secondary study, there was some evidence that the compensatory CR intervention improved memory at 6 months post-treatment and quality of life at 12 months but there was not a consistent pattern of improvement compared to controls.
Generalizability from civilian and veteran communities to active duty SMs may pose some unique and unexplored factors as the goal of treatment is not remediation of common activities of daily living (e.g., remembering appointments) but in contrast, the goal is military readiness needed for worldwide deployability to potential wartime environments (e.g., "cognitive readiness").
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Primary Aim: Difference in Cognitive and Neurophysiological Function between SMART and TCR. Multilevel mixed-effect modeling will be conducted for Aim 1 with treatment modality (SMART vs. TCR) as the independent variable. This approach will take into consideration between-subject variance based on randomized group, as well as within-subject variance for repeated measures. Primary analyses will be based on intention to treat, and we will leverage the statistical power of multilevel modeling to handle missing follow-up data. Outcome will be assessed as change in GDS over time. A significant p-value of 0.05 will be used to assess the main effects.
| Arm | Type | Receives |
|---|---|---|
| SMART INTERVENTION | Experimental | Other: Strategic Memory Advanced Reasoning TrainingN= 81 20 HOURS THERAPY IMMEDIATE POST TREATMENT EVALUATION 3 MONTH POST TREATMENT EVALUATION |
| TCR | Experimental | Other: Traditional Cognitive RehabilitationN= 81 60 HOURS THERAPY IMMEDIATE POST TREATMENT EVALUATION 3 MONTH POST TREATMENT EVALUATION |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- • Male or female ages 18 years or older
Key exclusion criteria (6 listed)
- • History of TBI (any severity) within 3 months of enrollment.
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 |
|---|---|---|
| Strategic Memory Advanced Reasoning TrainingSMART focuses on three metacognitive strategies: Strategic Attention, Integrated Reasoning and Innovation. | Other | SMART INTERVENTION |
| Traditional Cognitive RehabilitationParticipants randomized to the TCR condition will participate in a clinician-directed intervention that provides manualized, traditional clinician-directed cognitive rehabilitation that was developed for the SCORE trial (Cooper et al., 2017) | Other | TCR |
Primary outcome
Change in cognitive impairment
Time frame: 4 MONTHS
Cognitive impairment will be measured using the Global Deficit Score (GDS) which allows for the detection of subtle and varied degree of impairment from multiple measures.
2 secondary outcomes
Change in healthcare utilization
Time frame: 4.5 MONTHS
Change in level of occupational performance
Time frame: 4.5 MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- 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.
MELISSA JENSEN contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strategic Memory Advanced Reasoning Training and Traditional Cognitive Rehabilitation in people with Mild Traumatic Brain Injury, run by The Defense and Veterans Brain Injury Center 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 7 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: status not confirmed, as of the sponsor's last update on 3 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angela G Basham, MPH (7607194201, ANGELA.G.BASHAM.CTR@MAIL.MIL), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive impairment (time frame: 4 MONTHS). 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 3 Feb 2021.