Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT05664620

Conditions

Post-Concussion Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Risk Stratification Tool

Study Details

Brief summary:

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).

Conditions

Post-Concussion Syndrome

Study ID

NCT05664620

Start date

Feb 17, 2021

Status verified date

Dec, 2022

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Aug 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age between 18-60 years old
2. Clinical diagnosis of PCS for 1-12 months with at least 3 symptoms
3. Must be employed at time of injury
4. Full-time or part-time worker prior to concussion and cannot return to work
5. Must speak English and be sufficiently literate to complete questionnaires and perform assessments
6. Must be able to give consent

Exclusion Criteria:

1. Abnormalities on MRI such as contusion, hemorrhages, siderosis, or other non-traumatic conditions
2. History of neurological conditions (e.g. stroke, seizures) or major psychiatric disease

Study Design

Enrollment

75 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

no intervention: Low risk

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

no intervention: Medium risk

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

other: High risk

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

Interventions

Risk Stratification Tool

Patients will be allocated to three groups (Low,medium and high risk) by using the Risk Stratification Tool, and High risk patients will receive multidisciplinary treatment assigned to them by a physician

Primary outcome measure

  • Return to work [ Time Frame: 12 months after treatment start day ]

Central Contacts and Locations

Central contacts

Mozhgan Khodadadi, MA

416-603-5800mozhgan.khodadadi@uhn.ca

Locations

Canadian Concussion Centre- Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Mozhgan Khodadadi, MA

416-603-5800mozhgan.khodadadi@uhn.ca

Principal Investigator:

Charles Tator, MD,PhD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 27, 2022

Last verified

Dec, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2022-12-27.