Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT03218332

Conditions

Chronic Traumatic Encephalopathy

Eligibility Criteria

Sex: Male

Age: 25 - 70+

Healthy Volunteers: Accepted

Interventions

Biomarkers for detecting possible CTE invivo

Study Details

Brief 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 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.

Conditions

Chronic Traumatic Encephalopathy

Study ID

NCT03218332

Start date

Jul 4, 2011

Status verified date

Sep, 2021

Completion date

Dec 30, 2030

Anticipated

Primary completion date

Dec 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 25 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Healthy controls

Active Comparator

Interventions

Biomarkers for detecting possible CTE invivo

Detection biomarkers for possible CTE: Imaging/blood/CSF/PET-tau/MRI/europsychological assessment

Primary outcome measure

  • Biomarkers for possible CTE [ Time Frame: several visits every two years up to 10 years ]

Central Contacts and Locations

Central contacts

Mozhgan Khodadadi, MA

416-603-5800Mozhgan.Khodadadi@uhn.ca

Locations

Canadian Concussion Centre, Toronto Western Hospital, University Health Network

Recruiting

Toronto, Ontario, Canada, M6J 3S3

Contacts

Mozhgan Khodadadi, MA

416-603-5800Mozhgan.Khodadadi@uhn.ca

Principal Investigator:

Maria C Tartaglia, M.D

More Information

Sponsor

University Health Network, Toronto

Last update posted

Sep 29, 2021

Last verified

Sep, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2021-09-29.