Trials Sponsors Conditions Drugs Pricing

Conditions

Traumatic Brain Injury

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)

Device: McDESPOT

Control Group

Control group (30 subjects) of age match non-contact sport players (scan, genetic testing, concussion assessment)

Interventions

McDESPOTDevice

myelin specific MRI sequence (mcDESPOT) added to standard MRI sequence

mTBI Study Group with McDESPOT sequence

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age13 Years - 18 Years

Sexmale(Gender-based eligibility)

Gender Eligibility DetailsMale high school football players

Age GroupsChild (0-17), Adult (18-64)

Sampling MethodNon-Probability Sample

Study Population

High school age (9th-12th grade), male, right-handed Diagnosed with concussion or mild traumatic brain injury

You may qualify if:

Experimental Group

Sponsors & Collaborators

Memorial Healthcare System
Otherlead

Study Sites (1)

Memorial Healthcare System

Hollywood, Florida, 33021, United States

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

Heather Spader, MD
Memorial Healthcare System
PRINCIPAL INVESTIGATOR

Enrollment

13 participants (actual enrollment reported by the registry).

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

Actual (reported)

Study Stopped

Myelin Imaging in Concussed High School Football Players

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

mTBI Study Group with McDESPOT sequence

Control Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

mTBI Study Group with McDESPOT sequence

Control Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations