Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-03-26 @ 11:23 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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070627', 'term': 'Chronic Traumatic Encephalopathy'}], 'ancestors': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020208', 'term': 'Brain Injury, Chronic'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and cerebrospinal fluid (CSF) will be collected.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2030-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2017-05-01', 'studyFirstSubmitQcDate': '2017-07-12', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biomarkers for possible CTE', 'timeFrame': 'several visits every two years up to 10 years', 'description': 'Neuropsychological/MRI/genetics/CSF/PET-tau/oculomotor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Traumatic Encephalopathy']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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:\n\n1. To determine the effects of repeated concussions on neurological, neuropsychological and psychosocial functioning.\n2. 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.\n3. To determine the relationship between repeated concussions and changes in the cerebrospinal fluid composition.\n4. To (i) establish the infrastructure to conduct ongoing pathological examination of donated brains.\n5. 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'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '25 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Retired professional athletes with history or multiple concussions and healthy control group without any history of concussion', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nfluent 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.\n\nExclusion Criteria:\n\nNeurological 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.'}, 'identificationModule': {'nctId': 'NCT03218332', 'briefTitle': 'Post-Concussion Syndrome in Professional Athletes: A Multidisciplinary Study', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Post-Concussion Syndrome in Professional Athletes: A Multidisciplinary Study', 'orgStudyIdInfo': {'id': '11-0088-B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Former concussed pro-athletes', 'description': '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.', 'interventionNames': ['Diagnostic Test: Biomarkers for detecting possible CTE invivo']}, {'label': 'Healthy controls', 'description': 'Active Comparator', 'interventionNames': ['Diagnostic Test: Biomarkers for detecting possible CTE invivo']}], 'interventions': [{'name': 'Biomarkers for detecting possible CTE invivo', 'type': 'DIAGNOSTIC_TEST', 'description': 'Detection biomarkers for possible CTE: Imaging/blood/CSF/PET-tau/MRI/europsychological assessment', 'armGroupLabels': ['Former concussed pro-athletes', 'Healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M6J 3S3', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Mozhgan Khodadadi, MA', 'role': 'CONTACT', 'email': 'Mozhgan.Khodadadi@uhn.ca', 'phone': '416-603-5800', 'phoneExt': '4025'}, {'name': 'Maria C Tartaglia, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Charles H Tator, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Canadian Concussion Centre, Toronto Western Hospital, University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Mozhgan Khodadadi, MA', 'role': 'CONTACT', 'email': 'Mozhgan.Khodadadi@uhn.ca', 'phone': '416-603-5800', 'phoneExt': '4025'}], 'overallOfficials': [{'name': 'Maria Carmela Tartaglia, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toronto Western Hopsital,UHN;Tanz CRND'}, {'name': 'Charles H Tator, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toronto Western Hopsital,UHN'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Weston A. Price Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Marion and Gerald Soloway Professorship in Brain Injury and Concussion Research,Assistant Professor', 'investigatorFullName': 'Carmela Tartaglia', 'investigatorAffiliation': 'University Health Network, Toronto'}}}}