Post-Concussion Syndrome in Professional Athletes: A Multidisciplinary Study

NCT03218332 | Recruiting

• 1 other identifier: 11-0088-B
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Biomarkers for possible CTE

  Neuropsychological/MRI/genetics/CSF/PET-tau/oculomotor

  several visits every two years up to 10 years

Study Arms (2)

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

Healthy controls

Active Comparator

Diagnostic Test: Biomarkers for detecting possible CTE invivo

Interventions

Biomarkers for detecting possible CTE invivo DIAGNOSTIC_TEST

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

Former concussed pro-athletes; Healthy controls

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• The Weston A. Price Foundation: collaborator

Study Sites (1)

Canadian Concussion Centre, Toronto Western Hospital, University Health Network

Toronto, Ontario, M6J 3S3, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and cerebrospinal fluid (CSF) will be collected.

MeSH Terms

Conditions

Chronic Traumatic Encephalopathy

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Injury, Chronic; Neurodegenerative Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Damage, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Maria Carmela Tartaglia, M.D

  Toronto Western Hopsital,UHN;Tanz CRND

  PRINCIPAL INVESTIGATOR

• Charles H Tator, M.D

  Toronto Western Hopsital,UHN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mozhgan Khodadadi, MA

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Marion and Gerald Soloway Professorship in Brain Injury and Concussion Research,Assistant Professor

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: July 14, 2017
• Study Start: July 4, 2011
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2030
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)