Concussion Clinical Trials

Find Concussion Clinical Trials Near You

Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C): RCT of In-person vs Telehealth vs Wait List Control

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Objectives: STAR-C, delivered in-person and via telehealth, will be effective in decreasing everyday cognitive complaints among patients with a history of mTBI. Effectiveness will be moderated by patient characteristics. Stakeholder feedback will yield a process map for broad implementation of STAR-C in varied clinical environments.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:

• mTBI defined per the VA/DoD Clinical Practice Guideline for the Management of Concussion-Mild Traumatic Brain Injury sustained in any context (deployment related or non-deployment-related) and at any time longer than 3 months previously.

• a score of 2, 3, or 4 on any of the four Cognitive items on the NSI, to include participants who have cognitive complaints.

• a score on the Word Reading Subtest of the Wide Range Achievement Test of a sixth-grade reading level or higher, to ensure participants can read study materials.

Locations
United States
Hawaii
Desmond T. Doss Health Clinic
RECRUITING
Wahiawa
Texas
Brooke Army Medical Center
RECRUITING
San Antonio
Contact Information
Primary
Marc Blaylock
marc.j.blaylock.ctr@health.mil
210-916-8693
Backup
Kalawena N Kalehuawehe
kalawena.n.kalehuawehe.ctr@health.mil
808-433-8553
Time Frame
Start Date: 2025-09-18
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 222
Treatments
Other: No Treatment Waitlist
Individuals randomized to this arm will go for 4 weeks without treatment. During this time, participants will be asked to remain stable on treatments that they are already receiving for their concussive symptoms; that is and should not start a new treatment or change their medication. At the end of the 4-week wait, participant's will be asked about any changes to treatments that they have received during this time, and participants will be asked to complete questionnaires. This visit can be complete in person or remotely. Participants will be randomized into the in-person or telemedicine group.
Other: In-Person STAR-C
Individuals assigned to this treatment will receive in-person individual cognitive rehabilitation treatment conducted by credentialed speech or occupational therapists. Participants will complete up to three sessions per week (approximately 50 minutes each) for up to nine sessions plus one wrap up session. The treatment will include a focus on compensatory strategies and weekly homework assignments. Participants will work on personalized targets and assignments. The treatment will end with one wrap up session where participants will put together a plan for maintenance of what they have learned with their therapist's help.
Other: Telehealth STAR-C
Individuals assigned to this treatment will receive individual cognitive rehabilitation treatment conducted by credentialed speech or occupational therapists via a telemedicine format. Participants will complete up to three sessions per week (approximately 50 minutes each) for up to nine sessions plus one wrap up session. The treatment will include a focus on compensatory strategies and weekly homework assignments. Participants will work on personalized targets and assignments. The treatment will end with one wrap up session where participants will put together a plan for maintenance of what they have learned with their therapist's help.
Related Therapeutic Areas
Sponsors
Collaborators: Brooke Army Medical Center, Tripler Army Medical Center
Leads: Henry M. Jackson Foundation for the Advancement of Military Medicine

This content was sourced from clinicaltrials.gov