Post-Concussion Syndrome in Professional Athletes: A Multidisciplinary Study

NCT ID: NCT03218332

Last Updated: 2021-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-04

Study Completion Date

2030-12-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Chronic Traumatic Encephalopathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Biomarkers for detecting possible CTE invivo

Intervention Type DIAGNOSTIC_TEST

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

Healthy controls

Active Comparator

Biomarkers for detecting possible CTE invivo

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Biomarkers for detecting possible CTE invivo

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Weston A. Price Foundation

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Carmela Tartaglia

Marion and Gerald Soloway Professorship in Brain Injury and Concussion Research,Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Carmela Tartaglia, M.D

Role: PRINCIPAL_INVESTIGATOR

Toronto Western Hopsital,UHN;Tanz CRND

Charles H Tator, M.D

Role: PRINCIPAL_INVESTIGATOR

Toronto Western Hopsital,UHN

Locations

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Canadian Concussion Centre, Toronto Western Hospital, University Health Network

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Mozhgan Khodadadi, MA

Role: CONTACT

416-603-5800 ext. 4025

Facility Contacts

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Mozhgan Khodadadi, MA

Role: primary

416-603-5800 ext. 4025

Other Identifiers

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11-0088-B

Identifier Type: -

Identifier Source: org_study_id

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