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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
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months after treatment start day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after treatment start day
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
1,476 Previous Clinical Trials
485,105 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of neurological conditions or major psychiatric disease.I have been diagnosed with PCS for 1-12 months and have at least 3 symptoms.I can speak English and fill out forms or assessments.I was working before my concussion and now can't return to work.I am between 18 and 60 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Low risk
- Group 2: Medium risk
- Group 3: High risk
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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