Post Concussion Symptoms Risk Stratification Tool

Post-Concussion Syndrome Clinical Trial

Official title:

Development of a Persisting Concussion Symptoms (PCS) Risk Stratification Tool and Evaluation of the Effectiveness of an Enhanced WSIB Multidisciplinary Individualized Treatment Program to Enhance Return to Work and Recovery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05664620
• Other study ID #: 20-6079
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2022
• Source: University Health Network, Toronto
• Contact: Mozhgan Khodadadi, MA
• Phone: 416-603-5800
• Email: mozhgan.khodadadi[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

The information from 500 hundred concussion patients were used to develop the PCS RST. This is a screening tool that will assist in predicting patient outcomes by allocating patients with PCS into a low, medium and high risk group for prolonged PCS symptoms. This categorization would help target those patients at high risk of prolonged symptoms with a multidisciplinary individualized treatment and evaluate the effectiveness of it on return to work and recovery. For this research study, we ask workers who have had concussions and are categorized as high high risk (with PCS RST) for prolonged PCS symptoms to undergo individualized treatments and we will examine their recovery and return to work.

The study will involve 75 patients with persisting concussion symptoms from the Canadian Concussion Centre clinics and Altum Health concussion clinic at Toronto Western Hospital.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-Concussion Syndrome

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Canada	Canadian Concussion Centre- Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Return to work	The Primary Outcome is the percentage of concussed workers who ultimately RTW one year after the treatment commences. The Recovery and Return to Work tracker will be completed in 3,6,9 and 12 months to track their recovery. However, the primary endpoint is "Return to work at 12 months."	12 months after treatment start day
Secondary	Work Quality	The type of work returned to in relation to the pre-concussion work and work stability in terms of being able to stay working after RTW. For this purpose, a modified work quality Index (WQI) will be used.	12 months after treatment start day