Post-Concussion Syndrome in Professional Athletes: A Multidisciplinary Study

Chronic Traumatic Encephalopathy Clinical Trial

Official title:

Post-Concussion Syndrome in Professional Athletes: A Multidisciplinary Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03218332
• Other study ID #: 11-0088-B
• Status: Recruiting
• Start date: July 4, 2011
• Est. completion date: December 30, 2030

Study information

• Verified date: September 2021
• Source: University Health Network, Toronto
• Contact: Mozhgan Khodadadi, MA
• Phone: 416-603-5800
• Email: Mozhgan.Khodadadi[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 30, 2030
• Est. primary completion date: December 30, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Diseases
• Brain Injuries, Traumatic
• Chronic Traumatic Encephalopathy
• Post-Concussion Syndrome

Intervention

Diagnostic Test:
• Biomarkers for detecting possible CTE invivo
Detection biomarkers for possible CTE: Imaging/blood/CSF/PET-tau/MRI/europsychological assessment

Locations

Country	Name	City	State
Canada	Canadian Concussion Centre, Toronto Western Hospital, University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	The Weston A. Price Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers for possible CTE	Neuropsychological/MRI/genetics/CSF/PET-tau/oculomotor	several visits every two years up to 10 years