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NCT Number: NCT03218332

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.

Recruiting

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Key information

Age range

25 year–85 year

Sex eligibility

Male

Study type

Observational

Primary location

Canadian Concussion Centre, Toronto Western Hospital, University Health Network

Toronto, Ontario, M6J 3S3, Canada

Location status: Recruiting

Location contact

Charles H Tator, M.D

PRINCIPAL_INVESTIGATOR

Maria C Tartaglia, M.D

PRINCIPAL_INVESTIGATOR

Mozhgan Khodadadi, MA

CONTACT

[email protected]

416-603-5800 ext. 4025

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biomarkers for detecting possible CTE invivo

Diagnostic Test

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

Primary outcomes

  1. Biomarkers for possible CTE

    Time frame: several visits every two years up to 10 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mozhgan Khodadadi, MA

CONTACT

[email protected]

416-603-5800 ext. 4025

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • The Weston A. Price Foundation

Registry information

Important dates

Study start
2011
Primary completion
2030
Study completion
2030
First posted
Jul 14, 2017
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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