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Risk Stratification Tool for Post-Concussion Syndrome

N/A
Recruiting
Led By Charles Tator, MD, 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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after treatment start day
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to identify patients w/ Persisting Concussion Symptoms who are at high risk of prolonged symptoms to provide better treatment.

Who is the study for?
This trial is for adults aged 18-60 who have been diagnosed with Post-Concussion Syndrome (PCS) for 1-12 months, are experiencing at least three PCS symptoms, were employed when injured and haven't returned to work. Participants must speak English, be able to complete questionnaires, give consent, and not have certain MRI abnormalities or a history of major neurological or psychiatric conditions.
What is being tested?
The study is testing a new tool designed to identify patients with PCS who are at high risk of prolonged symptoms. The goal is to validate this Risk Stratification Tool so that it can help target early intervention efforts more effectively and improve care for those most in need.
What are the potential side effects?
Since the intervention being studied is a risk assessment tool rather than a medical treatment, there are no direct side effects associated with its use.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after treatment start day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months after treatment start day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Return to work
Secondary study objectives
Work Quality

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: High riskExperimental Treatment1 Intervention
A multidisciplinary individualized treatment (personalized medicine) model of treating all post-concussion symptoms simultaneously including the following: Headache therapy, balance therapy, vestibular therapy, exercise therapy\* mental health support e.g. CBT and/or mindfulness meditation\* (with more specialized diagnosis and care where required), cognitive assessment and therapy, vision therapy, sleep assessment and therapy, physiotherapy, education sessions\*, occupational therapy These patients will be treated through the Altum Health Neurology Specialty Program \*Offered to all high risk patients
Group II: Low riskActive Control1 Intervention
Standard of care to treat post-concussion symptoms in the community
Group III: Medium riskActive Control1 Intervention
Patients who are assigned to the medium risk group will receive the same treatment as the low risk group for one month, after which they will be reassessed. If improving they will go into the low risk group, and if not improving they will go into the high risk group

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,523 Previous Clinical Trials
503,263 Total Patients Enrolled
3 Trials studying Post-Concussion Syndrome
300 Patients Enrolled for Post-Concussion Syndrome
Charles Tator, MD, PhDPrincipal InvestigatorUniversity Health Network, Toronto
1 Previous Clinical Trials
100 Total Patients Enrolled
1 Trials studying Post-Concussion Syndrome
100 Patients Enrolled for Post-Concussion Syndrome
Carmela Tartaglia, MDPrincipal InvestigatorUniversity Health Network, Toronto
3 Previous Clinical Trials
181 Total Patients Enrolled
1 Trials studying Post-Concussion Syndrome
100 Patients Enrolled for Post-Concussion Syndrome

Media Library

High risk Clinical Trial Eligibility Overview. Trial Name: NCT05664620 — N/A
Post-Concussion Syndrome Research Study Groups: Low risk, Medium risk, High risk
Post-Concussion Syndrome Clinical Trial 2023: High risk Highlights & Side Effects. Trial Name: NCT05664620 — N/A
High risk 2023 Treatment Timeline for Medical Study. Trial Name: NCT05664620 — N/A
~16 spots leftby Nov 2025
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