A Study of the Imaging, Genetics, Clinical Presentation, Diagnostics, and Progression of Chronic Traumatic Encephalopathy
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 16-002662
NCT ID: NCT02798185
Sponsor Protocol Number: H-34799
About this study
The purpose of this study is to collect and analyze neuroimaging, genetic markers, and clinical presentations and progressions of chronic traumatic encephalopathy to develop methods of diagnosing the disease during life.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Former NFL Players
- English as primary language.
- No MRI or Lumber Puncture (LP) contraindications.
- Have played ≥ 12 years of organized football (including ≥ 3 in college and ≥ 3 seasons in the NFL).
- Must have played one of following positions offensive lineman, defensive lineman, linebacker, tight end, wide receiver, running back, or defensive back.
- Agree to provide name and contact information of a study partner who will complete questionnaires regarding subject's mood, behavior, thinking and cognitive function should the subject enroll in the study.
Former Collegiate Football Players
- English as primary language.
- No MRI or Lumber Puncture (LP) contraindications.
- Must have played ≥ 6 years of organized football (with ≥ 3 years at the college level, but no organized football or other contact sport following college).
- Must have played one of following positions offensive lineman, defensive lineman, linebacker, tight end, wide receiver, running back, or defensive back.
- No military service.
- Agree to provide name and contact information of a study partner who will complete questionnaires regarding subject's mood, behavior, thinking and cognitive function should the subject enroll in the study.
Control Group
- English as primary language.
- No MRI or Lumber Puncture (LP) contraindications.
- No history of organized contact sports or known traumatic brain injury (TBI) and/or moderate/severe concussions.
- No history of participation in any of the following organized sports at any level: football, hockey, rugby, soccer, lacrosse, wrestling, boxing, gymnastics, martial arts, and kickboxing.
- No military service.
- Must have BMI ≥ 24.
- Agree to provide name and contact information of a study partner who will complete questionnaires regarding subject's mood, behavior, thinking and cognitive function should the subject enroll in the study.
- Must be asymptomatic when screened by telephone.
Exclusion Criteria:
Former NFL and Varsity Collegiate Football Players
- If they do not meet inclusion criteria.
- If they have a history of clinical stroke confirmed on neuroimaging.
- If they have vision or hearing impairment significant enough to compromise neuropsychological testing.
- If they are unable to undergo MRI/PET Scan.
- If they are unable to travel to one of 4 study sites to participate.
- If they cannot provide the name and contact information of an eligible study partner.
- If they are taking blood thinners that would make LP unsafe.
- If they do not agree to all study tests and procedures.
- If they are unable to consent to study procedures.
- If they have been hospitalized or treated in an emergency room following a severe injury to their head since they stopped playing football (severity determined on phone screening).
Control Group Exclusion:
- If they do not meet inclusion criteria.
- If they have vision or hearing impairment significant enough to compromise neuropsychological testing.
- If they are unable to undergo MRI/PET Scan.
- If they are unable to travel to one of 4 study sites to participate.
- If they cannot provide the name and contact information of an eligible study partner.
- If they report any cognitive concerns or dementia during screening process.
- If they are unable to consent to study procedures (during eligibility screening and the written consent for study procedures).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Charles Adler, M.D., Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available