An interventional study of Strategic Memory Advanced Reasoning Training and Traditional Cognitive Rehabilitation in Mild Traumatic Brain Injury, sponsored by The Defense and Veterans Brain Injury Center. Status unknown at 1 site in United States. Per ClinicalTrials.gov, last updated 2021-02-03.
Sponsored by The Defense and Veterans Brain Injury Center · Not applicable, Interventional, and Treatment
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.
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").
2,113 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.
This study's planned enrollment of 162 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →The Defense and Veterans Brain Injury Center is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Male or female ages 18 years or older
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:
Exclusion Criteria:
History of TBI (any severity) within 3 months of enrollment.
N= 81 20 HOURS THERAPY IMMEDIATE POST TREATMENT EVALUATION 3 MONTH POST TREATMENT EVALUATION
Other: Strategic Memory Advanced Reasoning Training
N= 81 60 HOURS THERAPY IMMEDIATE POST TREATMENT EVALUATION 3 MONTH POST TREATMENT EVALUATION
Other: Traditional Cognitive Rehabilitation
SMART focuses on three metacognitive strategies: Strategic Attention, Integrated Reasoning and Innovation.
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)
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.
Time frame: 4 MONTHS
Change in healthcare utilization
Healthcare utilization post-treatment, as measured by the number of medical appointments to rehabilitation specialists.
Time frame: 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).
Time frame: 4.5 MONTHS
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The Defense and Veterans Brain Injury Center