NCT05091970: STAR-C

Symptom-Targeted Approach to Rehabilitation for Concussion

Completed NA Last updated 15 May 2025

What this trial tests

NA trial testing Manualized cognitive rehabilitation for mild traumatic brain injury (mTBI) in Mild Traumatic Brain Injury in 58 participants. Completed in 30 October 2023.

Timeline

10 November 2021

Primary endpoint
30 October 2023

30 October 2023

Quick facts

Lead sponsor	South Texas Veterans Health Care System
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	58
Start date	10 November 2021
Primary completion	30 October 2023
Estimated completion	30 October 2023
Sites	2 locations across United States

Drugs / interventions tested

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

Conditions studied

• Mild Traumatic Brain Injury — all drugs for Mild Traumatic Brain Injury →

Sponsor

South Texas Veterans Health Care System

Who can join

Adults 18 to 65, any sex, with Mild Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.