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Post Concussion Symptoms Risk Stratification Tool

Primary Purpose

Post-Concussion Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Risk Stratification Tool
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Post-Concussion Syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age between 18-60 years old Clinical diagnosis of PCS for 1-12 months with at least 3 symptoms Must be employed at time of injury Full-time or part-time worker prior to concussion and cannot return to work Must speak English and be sufficiently literate to complete questionnaires and perform assessments Must be able to give consent Exclusion Criteria: Abnormalities on MRI such as contusion, hemorrhages, siderosis, or other non-traumatic conditions History of neurological conditions (e.g. stroke, seizures) or major psychiatric disease

Sites / Locations

  • Canadian Concussion Centre- Toronto Western HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Other

Arm Label

Low risk

Medium risk

High risk

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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."

Secondary Outcome Measures

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.

Full Information

First Posted
November 22, 2022
Last Updated
December 21, 2022
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT05664620
Brief Title
Post Concussion Symptoms Risk Stratification Tool
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2021 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Concussion Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low risk
Arm Type
No Intervention
Arm Description
Standard of care to treat post-concussion symptoms in the community
Arm Title
Medium risk
Arm Type
No Intervention
Arm Description
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
Arm Title
High risk
Arm Type
Other
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Risk Stratification Tool
Intervention Description
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 Information:
Title
Return to work
Description
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."
Time Frame
12 months after treatment start day
Secondary Outcome Measure Information:
Title
Work Quality
Description
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.
Time Frame
12 months after treatment start day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18-60 years old Clinical diagnosis of PCS for 1-12 months with at least 3 symptoms Must be employed at time of injury Full-time or part-time worker prior to concussion and cannot return to work Must speak English and be sufficiently literate to complete questionnaires and perform assessments Must be able to give consent Exclusion Criteria: Abnormalities on MRI such as contusion, hemorrhages, siderosis, or other non-traumatic conditions History of neurological conditions (e.g. stroke, seizures) or major psychiatric disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mozhgan Khodadadi, MA
Phone
416-603-5800
Ext
4025
Email
mozhgan.khodadadi@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Tator, MD, PhD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carmela Tartaglia, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Canadian Concussion Centre- Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mozhgan Khodadadi, MA
Phone
416-603-5800
Ext
4025
Email
mozhgan.khodadadi@uhn.ca
First Name & Middle Initial & Last Name & Degree
Charles Tator, MD,PhD
First Name & Middle Initial & Last Name & Degree
Carmela Tartaglia, MD

12. IPD Sharing Statement

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Post Concussion Symptoms Risk Stratification Tool

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