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Post Concussion Symptoms Risk Stratification Tool

NCT ID: NCT05664620

Last Updated: 2022-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-17

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Post-Concussion Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Low risk

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type OTHER

Risk Stratification Tool

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Tator, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Carmela Tartaglia, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Canadian Concussion Centre- Toronto Western Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Mozhgan Khodadadi, MA

Role: CONTACT

Phone: 416-603-5800

Email: [email protected]

Facility Contacts

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Mozhgan Khodadadi, MA

Role: primary

Other Identifiers

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20-6079

Identifier Type: -

Identifier Source: org_study_id