Chronic Traumatic EncephalopathyNCT03218332
Post-Concussion Syndrome in Professional Athletes: A Multidisciplinary Study
An observational study of Chronic Traumatic Encephalopathy, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
to examine the relationship between repeated concussions and late decline of brain function. In addition, all participants agreeing to participate in the study will be asked to will their brains to The Krembil Neuroscience Centre Concussion Project at the Toronto Western Hospital with the consent and full knowledge of… Read more about this study
- Who is it for?
- Ages 25 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Traumatic Encephalopathy
- What is being tested?
- Biomarkers for detecting possible CTE invivo
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jul 2011to 30 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 25 to 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Retired professional athletes with history or multiple concussions and healthy control group without any history of concussion
Who may be able to join
- fluent in English, and a history of multiple concussions , low exposures , or no concussions (Control group ). Determination of concussion exposure will be determined as follows: Previous concussion will be based on the player's recall of injury and defined as "an injury resulting from a blow to the head that caused an alteration in mental status and one or more of the following symptoms: headache, nausea, vomiting, dizziness/balance problems, fatigue, trouble sleeping, drowsiness, sensitivity to light or noise, blurred vision, difficulty remembering, and difficulty concentrating.
Who cannot join
- Neurological disorders prior to concussions (e.g.: seizure disorder); systemic illnesses known to affect the brain (e.g., diabetes and lupus); a history of psychotic disorder; known developmental disorders (e.g., attention deficit disorder, dyslexia); history of migraines; and, active engagement in litigation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Canadian Concussion Centre, Toronto Western Hospital, University Health Network
Toronto, Ontario, M6J 3S3
Mozhgan Khodadadi, MA, 416-603-5800 ext. 4025, Mozhgan.Khodadadi@uhn.ca
Maria C Tartaglia, M.D
About this study
to examine the relationship between repeated concussions and late decline of brain function. In addition, all participants agreeing to participate in the study will be asked to will their brains to The Krembil Neuroscience Centre Concussion Project at the Toronto Western Hospital with the consent and full knowledge of their families and doctors. However, it is possible to participate in the research without agreeing to a brain donation.
The Project Team is specifically attempting a clinical-MRI-brain tissue research analysis to determine the exact mechanism of the damage to brain tissue following repeated concussions. This condition is known as chronic traumatic encephalopathy (CTE), and shows an abnormal protein in the brain called tau-protein.
Read the detailed description
We hypothesize that repeated concussions in retired professional athletes will be associated with abnormalities in neurological, neuropsychological, biofluids and neuroimaging assessments. The primary objectives of the study are:
- To determine the effects of repeated concussions on neurological, neuropsychological and psychosocial functioning.
- To determine the relationship between repeated concussions and neuroanatomical abnormalities in brain gray and white matter subserving cognitive and motor functions using structural MRI assessment.
- To determine the relationship between repeated concussions and changes in the cerebrospinal fluid composition.
- To (i) establish the infrastructure to conduct ongoing pathological examination of donated brains.
- In order to investigate whether the effects of repeated concussions on brain function and brain structure are progressive and related to the condition known as Chronic Traumatic Encephalopathy, prospective, longitudinal, follow-up data will be collected
- Conditions
- Chronic Traumatic Encephalopathy
- Being tested
- Biomarkers for detecting possible CTE invivo
- Medical subject headings
- Chronic Traumatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarkers for detecting possible CTE invivoDiagnostic test
Detection biomarkers for possible CTE: Imaging/blood/CSF/PET-tau/MRI/europsychological assessment
| Study group | Role | What they receive |
|---|---|---|
| Former concussed pro-athletes | Biomarkers for detecting possible CTE invivo in former pro-athletes with multiple concussions: Imaging/blood/cerebrospinal fluid (CSF)/Positron emission tomography (PET-)tau/magnetic resonance imaging (MRI)/neuropsychological assessment. Receives: Diagnostic Test: Biomarkers for detecting possible CTE invivo | |
| Healthy controls | Active Comparator Receives: Diagnostic Test: Biomarkers for detecting possible CTE invivo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers for possible CTE
Neuropsychological/MRI/genetics/CSF/PET-tau/oculomotor
Measured: several visits every two years up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start4 Jul 2011
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Traumatic EncephalopathyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- The Weston A. Price Foundation
- Responsible party
- Principal investigator, Carmela Tartaglia, University Health Network, Toronto
- Investigators
- Maria Carmela Tartaglia, M.D, Principal investigator, Toronto Western Hopsital,UHN;Tanz CRNDCharles H Tator, M.D, Principal investigator, Toronto Western Hopsital,UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218332
- Sponsor's protocol ID
- 11-0088-B
- Status last verified
- Sep 2021
- First submitted
- 1 May 2017
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Concussion Syndrome in Professional Athletes: A Multidisciplinary Study
- ClinicalTrials.gov ID
- NCT03218332
- Acronym / sponsor ID
- 11-0088-B
- Conditions
- Chronic Traumatic Encephalopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- The Weston A. Price Foundation
- Study start
- 4 Jul 2011 (actual)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 14 Jul 2017 (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.
to examine the relationship between repeated concussions and late decline of brain function. In addition, all participants agreeing to participate in the study will be asked to will their brains to The Krembil Neuroscience Centre Concussion Project at the Toronto Western Hospital with the consent and full knowledge of their families and doctors. However, it is possible to participate in the research without agreeing to a brain donation.
The Project Team is specifically attempting a clinical-MRI-brain tissue research analysis to determine the exact mechanism of the damage to brain tissue following repeated concussions. This condition is known as chronic traumatic encephalopathy (CTE), and shows an abnormal protein in the brain called tau-protein.
Detailed description
We hypothesize that repeated concussions in retired professional athletes will be associated with abnormalities in neurological, neuropsychological, biofluids and neuroimaging assessments. The primary objectives of the study are:
- To determine the effects of repeated concussions on neurological, neuropsychological and psychosocial functioning.
- To determine the relationship between repeated concussions and neuroanatomical abnormalities in brain gray and white matter subserving cognitive and motor functions using structural MRI assessment.
- To determine the relationship between repeated concussions and changes in the cerebrospinal fluid composition.
- To (i) establish the infrastructure to conduct ongoing pathological examination of donated brains.
- In order to investigate whether the effects of repeated concussions on brain function and brain structure are progressive and related to the condition known as Chronic Traumatic Encephalopathy, prospective, longitudinal, follow-up data will be collected
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Former concussed pro-athletes | – | Diagnostic Test: Biomarkers for detecting possible CTE invivoBiomarkers for detecting possible CTE invivo in former pro-athletes with multiple concussions: Imaging/blood/cerebrospinal fluid (CSF)/Positron emission tomography (PET-)tau/magnetic resonance imaging (MRI)/neuropsychological assessment. |
| Healthy controls | – | Diagnostic Test: Biomarkers for detecting possible CTE invivoActive Comparator |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Retired professional athletes with history or multiple concussions and healthy control group without any history of concussion
Key inclusion criteria (1 listed)
- fluent in English, and a history of multiple concussions , low exposures , or no concussions (Control group ). Determination of concussion exposure will be determined as follows: Previous concussion will be based on the player's recall of injury and defined as "an injury resulting from a blow to the head that caused an alteration in mental status and one or more of the following symptoms: headache, nausea, vomiting, dizziness/balance problems, fatigue, trouble sleeping, drowsiness, sensitivity to light or noise, blurred vision, difficulty remembering, and difficulty concentrating.
Key exclusion criteria (1 listed)
- Neurological disorders prior to concussions (e.g.: seizure disorder); systemic illnesses known to affect the brain (e.g., diabetes and lupus); a history of psychotic disorder; known developmental disorders (e.g., attention deficit disorder, dyslexia); history of migraines; and, active engagement in litigation.
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 |
|---|---|---|
| Biomarkers for detecting possible CTE invivoDetection biomarkers for possible CTE: Imaging/blood/CSF/PET-tau/MRI/europsychological assessment | Diagnostic test | Former concussed pro-athletes, Healthy controls |
Primary outcome
Biomarkers for possible CTE
Time frame: several visits every two years up to 10 years
Neuropsychological/MRI/genetics/CSF/PET-tau/oculomotor
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Maria Carmela Tartaglia, M.D principal investigator
Toronto Western Hopsital,UHN;Tanz CRND
Charles H Tator, M.D principal investigator
Toronto Western Hopsital,UHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Traumatic Encephalopathy, 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 29 Sep 2021. 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?
This study is still under way. Results are not available in the source record yet.
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?
Biomarkers for possible CTE (time frame: several visits every two years up to 10 years). 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 29 Sep 2021.