Clinical trial NCT04245124: Validation of Cognitive Enhancement Techniques for Mild Traumatic Brain Injury
Official title: Validation of Cognitive Enhancement Techniques for Mild Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Traumatic Brain Injury
Keywords: COGNITIVE REHABILITATION
Lead sponsor: The Defense and Veterans Brain Injury Center
Sponsor class: FED
Collaborators: name: The University of Texas at Dallas
First posted: 2020-01-28
Enrollment: 162
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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").

Eligibility criteria: 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:

    1. Any loss of consciousness (not to exceed 30 minutes)
    2. Any loss of memory for the events immediately before or after the injury (not to exceed 1 day)
    3. 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).

Exclusion Criteria:

* • 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.

Primary outcomes:
measure: Change in cognitive impairment
timeFrame: 4 MONTHS
Secondary outcomes:
measure: Change in healthcare utilization
timeFrame: 4.5 MONTHS
measure: Change in level of occupational performance
timeFrame: 4.5 MONTHS
Other outcomes:
Locations:
city: Oceanside
country: United States
facility: Naval Hospital Camp Pendleton
state: California
Study officials:
References: