Post-Concussion SyndromeNCT05664620
Post Concussion Symptoms Risk Stratification Tool
A study testing Risk Stratification Tool in people with Post-Concussion Syndrome, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post-Concussion Syndrome
- What is being tested?
- Risk Stratification Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- 17 Feb 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Canadian Concussion Centre- Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Mozhgan Khodadadi, MA, 416-603-5800 ext. 4025, mozhgan.khodadadi@uhn.ca
Charles Tator, MD,PhD
About this study
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
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).
Read the 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.
- Conditions
- Post-Concussion Syndrome
- Being tested
- Risk Stratification Tool
- Medical subject headings
- Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk Stratification ToolDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Risk Stratification Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 12 months after treatment start day
Secondary outcomes (1)
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.
Measured: 12 months after treatment start day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start17 Feb 2021
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Concussion SyndromeStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Tator, MD, PhD, Principal investigator, University Health Network, TorontoCarmela Tartaglia, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664620
- Sponsor's protocol ID
- 20-6079
- Status last verified
- Dec 2022
- First submitted
- 22 Nov 2022
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05664620
- Acronym / sponsor ID
- 20-6079
- Conditions
- Post-Concussion Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Diagnostic Test: Risk Stratification ToolA 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk Stratification ToolPatients 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 | Diagnostic test | High risk |
Primary outcome
Return to work
Time frame: 12 months after treatment start day
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."
1 secondary outcome
Work Quality
Time frame: 12 months after treatment start day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Tator, MD, PhD principal investigator
University Health Network, Toronto
Carmela Tartaglia, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk Stratification Tool in people with Post-Concussion Syndrome, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mozhgan Khodadadi, MA (416-603-5800 ext. 4025, mozhgan.khodadadi@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to work (time frame: 12 months after treatment start day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2022.