Validation of Cognitive Enhancement Techniques for Mild Traumatic Brain Injury

Status unconfirmed · Not applicable

Conditions studied: Mild Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT04245124

Run by

The Defense and Veterans Brain Injury Center

People needed

162

Starts

2021-02-01

Expected to finish

2024-09-30

Last updated by the study team

2021-02-03

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• • 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).

You may not qualify if…

• • 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.

Where it is running

• Naval Hospital Camp Pendleton — Oceanside, California, United States (enrolling)

Full record on ClinicalTrials.gov

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