Status:
COMPLETED
Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Concussion Assessment
Lead Sponsor:
ElMindA Ltd
Collaborating Sponsors:
GE Healthcare
Conditions:
Concussion, Mild
TBI (Traumatic Brain Injury)
Eligibility:
All Genders
15-50 years
Brief Summary
mTBI is widely recognized as a major public health concern in the United States and worldwide. mTBI diagnosis remains a clinical challenge as no single test can diagnose every concussion. Recent advan...
Detailed Description
Mild traumatic brain injury (mTBI), also known as concussion, occurs commonly in sport and Motor Vehicle accidents. The Centers for Disease Control and Prevention estimate that as many as 3.8 million ...
Eligibility Criteria
Inclusion
- Enrolled in Arm 1 -mTBI group in the GE study: Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 study
- Enrolled in Arm 2 -non TBI group in the GE study: Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 study
- Males and females Aged 15-50
- Willingness to participate in the companion study and the ability to give informed assent (for children) and/or consent (for the parent of a minor or adults aged 18 years of age or older for themselves).
Exclusion
- Hair types which might preclude appropriate scalp electrode cap fit. E.g: dread locks, corn rows etc.
- Significant sensory deficit e.g.: Deafness, and/or blindness
- Open scalp wound
- Active head lice infection
Key Trial Info
Start Date :
January 26 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 16 2018
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03265912
Start Date
January 26 2017
End Date
January 16 2018
Last Update
September 27 2018
Active Locations (2)
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1
Hospital for Special surery
New York, New York, United States, 10021
2
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213