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: Unknown

75 Participants Needed

Trial Summary

What is the purpose of this trial?

Patients with Persisting Concussion Symptoms (PCS) have a multitude of different symptoms. Some patients are at risk of prolonged symptoms but currently there is no tool to assist in identifying patients at high risk. Intensive, multidisciplinary intervention is time-consuming and expensive and may not be warranted for all PCS patients, so it is essential to identify early on which patients are at risk of prolonged symptoms. The aim of this study is to improve the quality of care delivered to patients, especially those who are at high-risk of prolonged PCS by early identification and treatment of all the symptoms. The purpose of this research is to validate the use of a Persisting Concussion Symptoms (PCS) Risk Stratification Tool (RST).

Research Team

Charles Tator, MD, PhD

Principal Investigator

University Health Network, Toronto

Carmela Tartaglia, MD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

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 can speak English and fill out forms or assessments.

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.

Treatment Details

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.

Participant Groups

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+