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Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C)

Study acronym: STAR-C
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 7, 2025 to Sep 18, 2025
    • Eligibility criteria expanded, about 26 words
    • Site details revised at 2 of 2 sites
    v5
  2. Start date: Apr 1, 2025 to Jul 7, 2025v4
  3. 2 versions Re-verified since Mar 4, 2025, no change to tracked fieldsv2-v3
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Purpose: Investigators propose a three-arm RCT across two military treatment facilities:1) in-person STAR-C, 2) telehealth STAR-C, and 3) no treatment control. Outcomes will be assessed immediately and at one- and three-months post treatment. Hypothesis/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.
Trial Details
NCT Number NCT06855186
Lead Sponsor Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators: Brooke Army Medical Center, Tripler Army Medical Center
Conditions
(from sponsor)		 Mild Traumatic Brain Injury (mTBI)
Related terms Brain Concussion, Brain Injuries
Enrollment 222 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov