Post Concussion Symptoms Risk Stratification Tool

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

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).

Study Overview

• Status: Recruiting
• Conditions: Post-Concussion Syndrome
• Intervention / Treatment: Diagnostic test: Risk Stratification Tool

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Recruiting
      • Canadian Concussion Centre- Toronto Western Hospital
      • Principal Investigator: Carmela Tartaglia, MD
      • Principal Investigator: Charles Tator, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Charles Tator, MD, PhD, University Health Network, Toronto; Principal Investigator: Carmela Tartaglia, MD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2021
• Primary Completion (Anticipated): August 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Actual): December 27, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Concussion; Head Injuries, Closed; Wounds, Nonpenetrating; Post-Concussion Syndrome
• Other Study ID Numbers: 20-6079

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No