← Back to Search

Therapy Group 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

STAR-C2 Trial 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.Check my eligibility

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.See study design

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.

STAR-C2 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence to Intervention

Recruitment Rate

Secondary outcome measures

Acceptability of the Appropriateness

Acceptability of the Feasibility

Acceptability of the Intervention

STAR-C2 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

~700

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor

884 Previous Clinical Trials

2,598,256 Total Patients Enrolled

Atlas Institute for Veterans and FamiliesUNKNOWN

2 Previous Clinical Trials

280 Total Patients Enrolled

Jackie Bosch, PhDPrincipal InvestigatorMcMaster University School of Rehabilitation Science

1 Previous Clinical Trials

100 Total Patients Enrolled

Media Library

Cognitive Rehabilitation Clinical Trial Eligibility Overview. Trial Name: NCT05520710 — N/A

Concussion Research Study Groups: Therapy Group, Educational Group

Concussion Clinical Trial 2023: Cognitive Rehabilitation Highlights & Side Effects. Trial Name: NCT05520710 — N/A

Cognitive Rehabilitation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05520710 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the study open to adults of eighteen and older?

"As per the trial's inclusionary standards, individuals aged 18 and above up to one hundred years old are welcome to participate."

Answered by AI

Are there any open enrollment opportunities for this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this medical trial has been posted since January 1st 2023 and was last updated on September 1st 2023. The research is actively recruiting 60 participants at a single location."

Answered by AI

What is the maximum number of participants accepted for this clinical study?

"Affirmative. According to the data posted on clinicaltrials.gov, this research project is actively enrolling participants. The trial was initially published on January 1st 2023 and most recently updated on September 1st 2023 with a goal of recruiting 60 individuals from one recruitment site."

Answered by AI

For what demographics is this experiment accepting participants?

"This clinical trial seeks to enroll 60 individuals with concussion who are aged between 18 and 100. Criteria for participation include being a fluent English speaker, having the capacity to attend four weeks of rehabilitation sessions (with potential rescheduling allowed), not already undergoing cognitive therapy by a registered health professional, access to electronic devices and internet connection, being an Armed Forces veteran of Canada residing in the community, over 18 years old without any prior history of neurological disorder affecting cognition reported by self."

Answered by AI

Recent research and studies

Journal of the American Geriatrics SocietyJournal

The Montreal Cognitive Assessment, Moca: A Brief Screening Tool for Mild Cognitive Impairment

Nasreddine, Ziad S., Natalie A. Phillips, ValÃ©rie BÃ©dirian, Simon Charbonneau, Victor Whitehead, Isabelle Collin, Jeffrey L. Cummings, and Howard Chertkow. 2005. “The Montreal Cognitive Assessment, Moca: A Brief Screening Tool for Mild Cognitive Impairment”. Journal of the American Geriatrics Society. Wiley. doi:10.1111/j.1532-5415.2005.53221.x.

The Clinical NeuropsychologistJournal

Normative Data for the Neurobehavioral Symptom Inventory (NSI) and Post-concussion Symptom Profiles Among TBI, PTSD, and Nonclinical Samples

Soble, Jason R., Marc A. Silva, Rodney D. Vanderploeg, Glenn Curtiss, Heather G. Belanger, Alison J. Donnell, and Steven G. Scott. 2014. “Normative Data for the Neurobehavioral Symptom Inventory (NSI) and Post-concussion Symptom Profiles Among TBI, PTSD, and Nonclinical Samples”. The Clinical Neuropsychologist. Informa UK Limited. doi:10.1080/13854046.2014.894576.

Implementation ScienceJournal

Psychometric Assessment of Three Newly Developed Implementation Outcome Measures

Weiner, Bryan J., Cara C. Lewis, Cameo Stanick, Byron J. Powell, Caitlin N. Dorsey, Alecia S. Clary, Marcella H. Boynton, and Heather Halko. 2017. “Psychometric Assessment of Three Newly Developed Implementation Outcome Measures”. Implementation Science. Springer Science and Business Media LLC. doi:10.1186/s13012-017-0635-3.

dsm-5Journal