Risk Stratification Tool for Post-Concussion Syndrome

Overseen By Mozhgan Khodadadi, MA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Neurological conditions, Major psychiatric disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a tool that identifies people at risk of long-lasting symptoms after a concussion. By spotting those who might need more intensive treatment early, the researchers aim to improve care for individuals with ongoing concussion issues. Participants will be grouped based on their risk level, with high-risk individuals receiving personalized care that addresses multiple symptoms simultaneously. The trial seeks individuals who have had a concussion and are struggling to return to work due to symptoms like headaches, dizziness, or trouble concentrating. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance concussion care for many.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this Risk Stratification Tool is safe for identifying patients at high risk of prolonged post-concussion symptoms?

Research has shown that a personalized treatment plan involving various types of care can be effective and safe for people with post-concussion syndrome (PCS). In one study, about 77% of participants reported significant improvement after receiving this treatment, demonstrating its effectiveness and ease of use for most individuals.

Another study found that patients achieved 81% of their therapy goals, suggesting the treatment is both feasible and beneficial for many. These studies reported no major side effects, indicating that the treatment is generally safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Risk Stratification Tool for post-concussion syndrome because it offers a personalized approach to treatment. Unlike the typical one-size-fits-all method, this tool identifies patients' risk levels—low, medium, or high—and tailors their care accordingly. High-risk patients receive a comprehensive, multidisciplinary treatment plan that addresses various symptoms simultaneously, including headache, balance, mental health, and more, offering a more holistic and targeted therapy. This customized strategy aims to optimize recovery by addressing individual needs, potentially improving outcomes for those affected by post-concussion syndrome.

What evidence suggests that this Risk Stratification Tool is effective for identifying patients at high risk of prolonged post-concussion symptoms?

This trial will use a Risk Stratification Tool to categorize participants into different risk groups for post-concussion syndrome (PCS). Research has shown that a personalized treatment plan involving various therapies can benefit people with ongoing PCS. In one study, 77% of patients experienced significant symptom improvement after receiving this type of care. Participants in the high-risk group of this trial will receive a multidisciplinary individualized treatment model, including therapies for headaches and balance, talk therapy, and physical exercises. Another review found that brain training, education about PCS, and gradually returning to physical activities helped manage PCS. These findings suggest that addressing multiple symptoms simultaneously with personalized care can improve outcomes for those with long-lasting PCS. ^{1 3 4 6 7}

Who Is on the Research Team?

Charles Tator, MD, PhD

Principal Investigator

University Health Network, Toronto

Carmela Tartaglia, MD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Must be employed at time of injury

I have been diagnosed with PCS for 1-12 months and have at least 3 symptoms.

I was working before my concussion and now can't return to work.

Exclusion Criteria

Abnormalities on MRI such as contusion, hemorrhages, siderosis, or other non-traumatic conditions

I have a history of neurological conditions or major psychiatric disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

High-risk patients undergo a multidisciplinary individualized treatment program including headache therapy, balance therapy, vestibular therapy, exercise therapy, mental health support, cognitive assessment and therapy, vision therapy, sleep assessment and therapy, physiotherapy, education sessions, and occupational therapy.

12 months

Monthly visits (in-person)

Follow-up

Participants are monitored for recovery and return to work, with assessments at 3, 6, 9, and 12 months after treatment start.

12 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Risk Stratification Tool

Trial Overview 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.

How Is the Trial Designed?

Group I: High risk Experimental Treatment 1 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 risk Active Control 1 Intervention

Standard of care to treat post-concussion symptoms in the community

Group III: Medium risk Active Control 1 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

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6948221/

Moving towards individualised and interdisciplinary ... Most patients recover well after a concussion but persistent PCS (PPCS) have been reported in 10% to 25% of patients [1]. Functional outcomes ...

2. cognitivefxusa.com cognitivefxusa.com/blog/post-concussion-syndrome-treatment-independent-study

Post-Concussion Syndrome Study: 77% See Improvement 77% of patients experienced a clinically significant reduction in symptoms after treatment. Statistical analysis showed improvements across all ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9604759/

A Systematic Review of Treatments of Post-Concussion ... Cognitive training, psycho-education, cognitive behavioral therapy, and graded return to physical activity demonstrated some effectiveness on persistent PCS.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1877065723000489

Interdisciplinary rehabilitation for persisting post- ... This study aimed to investigate the feasibility and preliminary efficacy of interdisciplinary treatment for reducing PPCSs beyond 4 weeks post-injury as a ...

5. biomedical-engineering-online.biomedcentral.com biomedical-engineering-online.biomedcentral.com/articles/10.1186/s12938-025-01380-x

Complexity of post-concussion syndrome assessment and ... The objective of this study was to define the effectiveness of a customized treatment program based on the findings of a standardized ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9338593/

a study protocol for a stepped-wedge cluster randomised trial Primary outcome is mean change in PCS measured by the Rivermead Post-Concussion Symptoms Questionnaire from enrolment to 3 months after end of ...

7. clinicaltrials.gov clinicaltrials.gov/show/NCT03034720

Collaborative Care Model for the Treatment of Persistent ... Collaborative care model for treatment of persistent symptoms after concussion among youth (CARE4PCS-II): Study protocol for a randomized, controlled trial.