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Trial record 6 of 155 for:    (Dementia pugilistica OR chronic traumatic encephalopathy)

Post-Concussion Syndrome in Professional Athletes: A Multidisciplinary Study

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ClinicalTrials.gov Identifier: NCT03218332
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
The Weston A. Price Foundation
Information provided by (Responsible Party):
Carmela Tartaglia, University Health Network, Toronto

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.


Condition or disease Intervention/treatment
Chronic Traumatic Encephalopathy 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

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Post-Concussion Syndrome in Professional Athletes: A Multidisciplinary Study
Actual Study Start Date : July 4, 2011
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

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




Primary Outcome Measures :
  1. Biomarkers for possible CTE [ Time Frame: several visits every two years up to 10 years ]
    Neuropsychological/MRI/genetics/CSF/PET-tau/oculomotor


Biospecimen Retention:   Samples With DNA
Blood and cerebrospinal fluid (CSF) will be collected.


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Retired professional athletes with history or multiple concussions and healthy control group without any history of concussion
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218332


Contacts
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Contact: Mozhgan Khodadadi, MA 416-603-5800 ext 4025 Mozhgan.Khodadadi@uhn.ca

Locations
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Canada, Ontario
Canadian Concussion Centre, Toronto Western Hospital, University Health Network Recruiting
Toronto, Ontario, Canada, M6J 3S3
Contact: Mozhgan Khodadadi, MA    416-603-5800 ext 4025    Mozhgan.Khodadadi@uhn.ca   
Principal Investigator: Maria C Tartaglia, M.D         
Principal Investigator: Charles H Tator, M.D         
Sponsors and Collaborators
University Health Network, Toronto
The Weston A. Price Foundation
Investigators
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Principal Investigator: Maria Carmela Tartaglia, M.D Toronto Western Hopsital,UHN;Tanz CRND
Principal Investigator: Charles H Tator, M.D Toronto Western Hopsital,UHN

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Responsible Party: Carmela Tartaglia, Marion and Gerald Soloway Professorship in Brain Injury and Concussion Research,Assistant Professor, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03218332     History of Changes
Other Study ID Numbers: 11-0088-B
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Brain Injuries, Traumatic
Chronic Traumatic Encephalopathy
Brain Injury, Chronic
Brain Diseases
Post-Concussion Syndrome
Central Nervous System Diseases
Nervous System Diseases
Brain Concussion
Head Injuries, Closed
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Wounds, Nonpenetrating
Brain Injuries
Neurodegenerative Diseases