Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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"). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04245124
Study type Interventional
Source The Defense and Veterans Brain Injury Center
Contact Angela G Basham, MPH
Phone 7607194201
Email ANGELA.G.BASHAM.CTR@MAIL.MIL
Status Recruiting
Phase N/A
Start date February 1, 2021
Completion date September 30, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04372797 - Standardized Instruments to Provide Diagnostic and Prognostic Information in Mild Traumatic Brain Injury (mTBI) N/A
Completed NCT01903525 - DHA For The Treatment of Pediatric Concussion Related to Sports Injury Phase 1
Completed NCT01847040 - Deployment Related Mild Traumatic Brain Injury (mTBI)
Completed NCT03678077 - Trends in Cohabitation Status, Academic Achievement and Socio-economic Indicators After Mild Traumatic Brain Injury
Recruiting NCT05682677 - Combined Neuromodulation and Cognitive Training for Post-mTBI Depression N/A
Terminated NCT03345550 - OPTIMA-TBI Pilot Study Phase 2
Completed NCT05095012 - RECOVER Clinical Pathway for Pediatric Concussion N/A
Recruiting NCT05886400 - The Effects of Environmental Distractions on SCAT6 Outcomes N/A
Recruiting NCT05262361 - Persistent Post-Concussion Symptoms With Convergence Insufficiency N/A
Active, not recruiting NCT03892291 - Objective Dual-task Turning Measures for Return-to-duty Assessments
Completed NCT03688984 - Treatment of Insomnia for Adolescents With Mild Traumatic Brain Injury N/A
Completed NCT02057081 - Multifamily Group to Reduce Marital Conflict and Disability in Veterans With mTBI N/A
Recruiting NCT06233851 - t-BIOMAP : Prospective Paediatric Cohort Study of Blood Biomarkers in mTBI
Completed NCT02844946 - One-Day Life Skills Workshop for Veterans With TBI, Pain and Psychopathology N/A
Completed NCT04641767 - BIOmarkers of TRAumatic Brain Injury Spain (BIOTRABIS)
Recruiting NCT06112093 - Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches N/A
Recruiting NCT03819608 - Neuromodulation and Neurorehabilitation for mTBI Plus PTSD N/A
Withdrawn NCT00580918 - Functional MRI Study of Attention in Normal Controls and Traumatic Brain Injured Patients
Completed NCT03319966 - Eyetracking and Neurovision Rehabilitation of Oculomotor Dysfunction in Mild Traumatic Brain Injury
Recruiting NCT03846830 - Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation N/A