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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
Clinical diagnosis of PCS for 1-12 months with at least 3 symptoms
Full-time or part-time worker prior to concussion and cannot return to work
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after treatment start day
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with PCS for 1-12 months and have at least 3 symptoms.
Select...
I was working before my concussion and now can't return to work.
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I can speak English and fill out forms or assessments.
Select...
I am between 18 and 60 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Return to work
Secondary outcome measures
Work Quality

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
1,468 Previous Clinical Trials
484,444 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

Frequently Asked Questions

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

Is it possible to register for participation in this clinical trial?

"Applicants for this medical trial must have post-concussion syndrome and be between 18-60 years old. 75 patients are needed to complete the study."

Answered by AI

Does this study extend to geriatric participants?

"This trial is specifically for patients between 18 and 60 years old. For those younger or older than this age range, there are 11 studies and 19 studies respectively designed to accommodate them."

Answered by AI

Are there any openings for enrollment in this clinical trial?

"Affirmative. According to records posted on clinicaltrials.gov, the study is still running and recruiting participants for its trial which was first made available in February 2021 and last edited in December 2022. 75 individuals are needed from one research facility."

Answered by AI

How many participants are receiving this trial-based treatment?

"Indeed, the clinicaltrials.gov database states that this medical trial is presently enrolling patients. It was first posted on February 17th 2021 and later updated December 21st 2022. This research requires 75 participants to be recruited from a single site."

Answered by AI
~7 spots leftby Aug 2024