Post Concussion Symptoms Risk Stratification Tool

NCT05664620 | Unknown

• 1 other identifier: 20-6079
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Work Quality

  12 months after treatment start day

Study Arms (3)

Low risk

NO INTERVENTION

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

Medium risk

NO 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

High risk

OTHER

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

Interventions

Risk Stratification Tool DIAGNOSTIC_TEST

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

High risk

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Canadian Concussion Centre- Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Post-Concussion Syndrome

Condition Hierarchy (Ancestors)

Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Charles Tator, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Carmela Tartaglia, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mozhgan Khodadadi, MA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 27, 2022
• Study Start: February 17, 2021
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 27, 2022

Record last verified: 2022-12

Locations

CA (1)