Post-Concussion Syndrome in Professional Athletes: A Multidisciplinary 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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Traumatic Encephalopathy
• Intervention / Treatment: Diagnostic test: Biomarkers for detecting possible CTE invivo

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:

1. To determine the effects of repeated concussions on neurological, neuropsychological and psychosocial functioning.
2. 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.
3. To determine the relationship between repeated concussions and changes in the cerebrospinal fluid composition.
4. To (i) establish the infrastructure to conduct ongoing pathological examination of donated brains.
5. 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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M6J 3S3
      • Recruiting
      • Canadian Concussion Centre, Toronto Western Hospital, University Health Network
      • Principal Investigator: Charles H Tator, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Retired professional athletes with history or multiple concussions and healthy control group without any history of concussion

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Biomarkers for detecting possible CTE invivo; Detection biomarkers for possible CTE: Imaging/blood/CSF/PET-tau/MRI/europsychological assessment
Healthy controls; Active Comparator	Diagnostic test: Biomarkers for detecting possible CTE invivo; Detection biomarkers for possible CTE: Imaging/blood/CSF/PET-tau/MRI/europsychological assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers for possible CTE	Neuropsychological/MRI/genetics/CSF/PET-tau/oculomotor	several visits every two years up to 10 years

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: The Weston A. Price Foundation
• Investigators: Principal Investigator: Maria Carmela Tartaglia, M.D, Toronto Western Hopsital,UHN;Tanz CRND; Principal Investigator: Charles H Tator, M.D, Toronto Western Hopsital,UHN

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2011
• Primary Completion (Anticipated): December 30, 2030
• Study Completion (Anticipated): December 30, 2030

Study Registration Dates

• First Submitted: May 1, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (Actual): July 14, 2017

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Neurodegenerative Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Concussion; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injury, Chronic; Brain Injuries, Traumatic; Brain Diseases; Post-Concussion Syndrome; Chronic Traumatic Encephalopathy
• Other Study ID Numbers: 11-0088-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No