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Cognitive Rehabilitation for Concussion (STAR-C2 Trial)

N/A

Recruiting

Led By Jackie Bosch, PhD

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing 2 methods to help improve brain function in CAF veterans with mTBI. Education vs. therapy from an OT or SLP. Pilot data will be used for future RCTs.

Who is the study for?

This trial is for Canadian Armed Forces veterans over 18 who have had a mild traumatic brain injury and are not currently in cognitive rehab. Participants must be able to commit to a 4-week program, use Zoom on an electronic device, speak fluent English, and have no history of neurological issues affecting cognition.

What is being tested?

The study compares two approaches to improve thinking skills after a concussion: one group receives educational materials while the other gets personalized therapy from professionals. It's a small-scale test run before launching a larger study.

What are the potential side effects?

Since this trial involves education and cognitive rehabilitation rather than medication, side effects are minimal but may include fatigue or frustration during the learning process.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence to Intervention

Recruitment Rate

Secondary study objectives

Acceptability of the Appropriateness

Acceptability of the Feasibility

Acceptability of the Intervention

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Therapy GroupExperimental Treatment1 Intervention

The Therapy Group will receive 6-10 individual sessions of 30-60 minutes each, delivered by a trained Occupational Therapist or Speech-Language Pathologist. The therapy will be delivered over a 4-week timeframe, with the total number of sessions per participant depending on the number of sessions needed to achieve their treatment targets. Each participant in the Therapy Group will identify three cognitive targets for treatment. Progress in reaching those targets will be documented using Goal Attainment Scaling (GAS)

Group II: Educational GroupActive Control1 Intervention

The education group will receive information about self-management of cognitive symptoms at the time of randomization, a common intervention for adults with mild Traumatic Brain Injury.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Rehabilitation

2009

N/A

~760

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