CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 58 enrolled
Drug / intervention
Manualized cognitive rehabilitation for mild traumatic brain injury (mTBI)procedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05091970
NCT05091970N/ACompleted

Symptom-Targeted Approach to Rehabilitation for Concussion: STAR-C

South Texas Veterans Health Care System·interventional·Posted Oct 25, 2021·Updated May 15, 2025

In Brief

A clinical study evaluating Manualized cognitive rehabilitation for mild traumatic brain injury (mTBI) for Mild Traumatic Brain Injury. Completed, enrolled 58 participants across 2 sites.

Detailed Summary

Throughout the course of the wars in Iraq and Afghanistan, more than 250,000 service members sustained traumatic brain injuries, mostly characterized as mild traumatic brain injuries (mTBI) or concussions. While most with mTBI recover over days to weeks, a significant percentage continue to experience post-concussive symptoms such as headaches, cognitive difficulties, and dizziness for months to years. As a result, treatment of post-concussive symptoms after mTBI is of significant importance in the Department of Defense and Veterans healthcare systems. Several studies have shown that cognitive rehabilitation can be effective for individuals with mTBI, including Service Members and Veterans with post concussive symptoms. Cognitive rehabilitation is a type of treatment in which patients work with a therapist to improve everyday memory and thinking skills and develop strategies to reduce the impact of cognitive difficulties in their everyday lives. While these treatments have great potential benefits, protocols studied to date are time intensive, requiring up to 60 hours of treatment. These time demands are impractical for many Service Members and Veterans, and place a time-burden on clinics providing the treatment. The current study proposes to identify key ingredients of an evidence-based cognitive rehabilitation protocol to develop a streamlined version that is feasible and acceptable to Service Members and Veterans. This briefer protocol will increase the number of Service Members and Veterans who can access treatment. To accomplish this goal the investigators will first spend six months analyzing manualized treatments from a successful cognitive rehabilitation intervention developed for Service Members. The investigators will analyze manuals using a framework developed to identify active ingredients in rehabilitation. Based on those results the investigators will develop a manualized streamlined treatment protocol, which the investigators will deliver to 25 Service Members and 50 Veterans over 18 months in person or via telehealth. The investigators will determine feasibility and acceptability of this intervention, and collect preliminary efficacy data. The project addresses access to therapy services and enhanced treatment compliance, a key barrier to participation in cognitive rehabilitation by Veterans and Service Members with TBI. Additionally, although this study focuses on Service Members and Veterans with mTBI, the investigators expect that this streamlined intervention can also be translated to civilian populations with mTBI.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedOct 25, 2021
Enrollment StartNov 10, 2021
Primary CompletionOct 30, 2023
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 4.7 years ago

Interventions

Manualized cognitive rehabilitation for mild traumatic brain injury (mTBI)procedure

Three 60-minute sessions per week with a minimum of 6 sessions and a maximum of 10 sessions. This intervention is to be delivered by trained Occupational Therapists (OTs) and Speech-Language Pathologists (SLPs), and includes training in compensatory strategies, direct training of cognitive subskills (e.g., attention training), and assigned homework to practice skills learned in treatment.