Recruiting

Cognitive Enhancement

Sponsor:

The Defense and Veterans Brain Injury Center

Code:

NCT04245124

Conditions

Mild Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Strategic Memory Advanced Reasoning Training

Traditional Cognitive Rehabilitation

Study Details

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.

Conditions

Mild Traumatic Brain Injury

Study ID

NCT04245124

Start date

Feb 1, 2021

Status verified date

Feb, 2021

Completion date

Sep 30, 2024

Anticipated

Primary completion date

Sep 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

162 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SMART INTERVENTION

N= 81 20 HOURS THERAPY IMMEDIATE POST TREATMENT EVALUATION 3 MONTH POST TREATMENT EVALUATION

experimental: TCR

N= 81 60 HOURS THERAPY IMMEDIATE POST TREATMENT EVALUATION 3 MONTH POST TREATMENT EVALUATION

Interventions

Strategic Memory Advanced Reasoning Training

SMART focuses on three metacognitive strategies: Strategic Attention, Integrated Reasoning and Innovation.

Traditional Cognitive Rehabilitation

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)

Primary outcome measure

  • Change in cognitive impairment [ Time Frame: 4 MONTHS ]

Central Contacts and Locations

Central contacts

Angela G Basham, MPH

7607194201ANGELA.G.BASHAM.CTR@MAIL.MIL

MELISSA JENSEN

melissa.a.jensen16.ctr@mail.mil

Locations

Naval Hospital Camp Pendleton

Recruiting

Oceanside, California, United States, 92055

Contacts

Angela Basham

Angela.g.basham.ctr@mail.mil

More Information

Sponsor

The Defense and Veterans Brain Injury Center

Last update posted

Feb 3, 2021

Last verified

Feb, 2021

Keywords

  • COGNITIVE REHABILITATION

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Defense and Veterans Brain Injury Center on 2021-02-03.