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Myelin Imaging in Concussed High School Football Players
A Prospective Study of Myelin Imaging Changes in Concussed High School Football Players
1 other identifier
observational
13
1 country
1
Brief Summary
Investigate myelin alterations in high school football players with mTBI
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 4, 2018
CompletedFirst Submitted
Initial submission to the registry
October 4, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2020
CompletedSeptember 25, 2020
September 1, 2020
1.9 years
October 4, 2018
September 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Myelin Disruption on MRI brain scan
Determine whether mTBI in football players leads to increased, but disorganized, myelin compared to non-contact sports players.
3 months
Secondary Outcomes (2)
APoE4 allele genetic mutation on blood test
3 months
Neuropsychiatric concussion correlation
3 months
Study Arms (2)
mTBI Study Group with McDESPOT sequence
Study group (30 subjects) of football players diagnosed with mTBI (scan at diagnosis, 3-month follow-up scan, genetic screening, concussion assessment at both interaction)
Control Group
Control group (30 subjects) of age match non-contact sport players (scan, genetic testing, concussion assessment)
Interventions
myelin specific MRI sequence (mcDESPOT) added to standard MRI sequence
Eligibility Criteria
High school age (9th-12th grade), male, right-handed Diagnosed with concussion or mild traumatic brain injury
You may qualify if:
- Experimental Group
- Patient age range: 9th through 12th grade (high school)
- Male
- Right-handed
- Diagnosis of mTBI or concussion during a football game or training
- No significant co-morbidities
- Able to get an MRI
- Potential subject must be capable of giving informed consent or assent when applicable
- Control Group
- Patient age range: 9th through 12th grade (high school)
- Male Right-handed
- Does not play contact sports (football, soccer, lacrosse)
- No significant co-morbidities
- Able to get an MRI
- Potential subject must be capable of giving informed consent or assent when applicable
You may not qualify if:
- Unable to tolerate MRI scan
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Healthcare System
Hollywood, Florida, 33021, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heather Spader, MD
Memorial Healthcare System
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2018
First Posted
October 9, 2018
Study Start
September 4, 2018
Primary Completion
August 12, 2020
Study Completion
August 12, 2020
Last Updated
September 25, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share