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| Name | Class |
|---|---|
| The University of Texas at Dallas | OTHER |
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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").
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMART INTERVENTION | Experimental | N= 81 20 HOURS THERAPY IMMEDIATE POST TREATMENT EVALUATION 3 MONTH POST TREATMENT EVALUATION |
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| TCR | Experimental | N= 81 60 HOURS THERAPY IMMEDIATE POST TREATMENT EVALUATION 3 MONTH POST TREATMENT EVALUATION |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strategic Memory Advanced Reasoning Training | Other | SMART focuses on three metacognitive strategies: Strategic Attention, Integrated Reasoning and Innovation. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 MONTHS |
| Measure | Description | Time Frame |
|---|---|---|
| Change in healthcare utilization | Healthcare utilization post-treatment, as measured by the number of medical appointments to rehabilitation specialists. | 4.5 MONTHS |
| Change in level of occupational performance |
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Inclusion Criteria:
• 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:
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).
Exclusion Criteria:
• History of TBI (any severity) within 3 months of enrollment.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angela G Basham, MPH | Contact | 7607194201 | ANGELA.G.BASHAM.CTR@MAIL.MIL | |
| MELISSA JENSEN | Contact | melissa.a.jensen16.ctr@mail.mil |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Hospital Camp Pendleton | Recruiting | Oceanside | California | 92055 | United States |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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.
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| Traditional Cognitive Rehabilitation | Other | 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) |
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Ratings of occupational performance by a direct supervisor using a modified Checklist of Military Activities of Daily Living (M-ADL).
| 4.5 MONTHS |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |