Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-06 @ 9:03 PM
Study NCT ID:
NCT03218332
Status:
RECRUITING
Last Update Posted:
2021-09-29
First Post:
2017-05-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Concussion Syndrome in Professional Athletes: A Multidisciplinary Study
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
Post-Concussion Syndrome in Professional Athletes: A Multidisciplinary Study
Status:
RECRUITING
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: