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Behavioural Intervention
Rehabilitation for Persistent Concussion Symptoms
N/A
Recruiting
Led By Milos R Popovic, PhD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Meet the definition of postconcussion syndrome, which requires a participant to report any 3 symptoms or more lasting at least 1-month following the diagnosis of a concussion
Have adequate language skills in English to read and take part in rehabilitation treatment program
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; 6-weeks; 12-weeks
Awards & highlights
Study Summary
This trial will compare individualized rehabilitative treatments to an active control to see how they affect recovery from post-concussion syndrome.
Who is the study for?
Adults over 21 with post-concussion syndrome, experiencing at least three symptoms for more than a month after a concussion. They must be able to read and understand English for the rehab program. Excluded are those with moderate/severe brain injury prior to enrollment, other neurological disorders, ongoing litigation related to their injury, certain medical conditions or treatments, long-term psychoactive medication use, pacemakers or high cardiovascular risk.Check my eligibility
What is being tested?
The trial is testing individualized rehabilitative therapy against usual care therapy for persistent concussion symptoms. It's a crossover study where participants receive one treatment for six weeks then switch to the other. Recovery is measured using symptom questionnaires and EEG before and after each phase.See study design
What are the potential side effects?
Since both interventions are non-pharmacological therapies focusing on rehabilitation rather than drugs, side effects may include discomfort from physical activities or fatigue due to cognitive exercises but no medicinal side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had three or more symptoms for over a month after my concussion.
Select...
I can read and speak English well enough to participate in a rehab program.
Select...
I am 21 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline; 6-weeks; 12-weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; 6-weeks; 12-weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rivermead Postconcussion Questionnaire
Secondary outcome measures
Brain Vital Sign
Neck Disability Index (NDI)
Patient Health Questionnaire (PHQ-9)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Individualized care programExperimental Treatment1 Intervention
Participants in the individualized care stream, will be provided reassurance and psychoeducation via the bio-psycho-social model on understanding persistent symptoms consistent with usual care. Additionally, they will be afforded up to 12 treatments over the course of 6-weeks. Treatments will be standardized; however, given the heterogeneity of symptoms, components of the treatments will be individualized to the participants based on what subgroup they're classified into at baseline based on their initial clinical examination and self-reported dominant impairment. Regardless of subgroup classification, as part of individualized care, all patients will receive reassurance and psychoeducation about the bio-psycho-social understanding of persistent symptoms, including advice on adaptive illness behaviours, such as gradually resuming premorbid activities and avoiding excessive rest and "all-or-nothing behaviour".
Group II: Usual careActive Control1 Intervention
Active control - All participants in the active control group will receive 'usual care', (twice a week for 6 weeks), which will consist of reassurance and psychoeducation via the bio-psycho-social model on understanding persistent symptoms, including advice on adaptive illness behaviours, such as gradually resuming premorbid activities and avoiding excessive rest and "all-or-nothing behaviour". Additionally, participants will be afforded weekly 20-minute supervised progressive sub-symptom aerobic exercise sessions at the KITE clinic under the supervision of study coordinator. They will be instructed to also perform daily 20-minutes of subsymptom aerobic exercise outside the supervised exercise sessions.
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Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,476 Previous Clinical Trials
485,130 Total Patients Enrolled
3 Trials studying Post-Concussion Syndrome
325 Patients Enrolled for Post-Concussion Syndrome
NeuroCatch Inc.Industry Sponsor
7 Previous Clinical Trials
359 Total Patients Enrolled
Milos R Popovic, PhDPrincipal InvestigatorUniversity Health Network, Toronto
2 Previous Clinical Trials
48 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment open for this research endeavor?
"The clinical trial is actively enrolling participants at this time, as stated on the official website of clinicaltrials.gov. Initiated in January 30th 2023 and most recently updated on October 2nd 2023."
Answered by AI
How many participants are being accepted into this research trial?
"Confirmed. Clinicaltrials.gov's records show that this research is actively enrolling patients, with the initial listing dating back to January 30th 2023 and most recent update from October 2nd of the same year. The investigation requires 50 people for a single medical centre."
Answered by AI
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