Status:
WITHDRAWN
Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Concussion Assessment, Young Adults and Adults
Lead Sponsor:
ElMindA Ltd
Conditions:
Concussion, Brain
Eligibility:
All Genders
12-50 years
Brief Summary
Concussion is widely recognized as a major public health concern in the United States and worldwide. Although many concussions resolve completely and spontaneously, almost 1 in 4 patients will go on t...
Detailed Description
Mild traumatic brain injury, also known as concussion, occurs commonly in sport. The Centers for Disease Control and Prevention estimate that as many as 3.8 million sport-related concussions occur ann...
Eligibility Criteria
Inclusion
- Males and females Aged 12-50
- Willingness to participate in the 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).
- Subjects that are or were diagnosed with mTBI according to the standard diagnostic procedures at the investigational site in a timeframe that meets enrollment criteria.
- Subjects that are experiencing symptoms of concussion or Post-concussion Syndrome at the time of their initial test session.
Exclusion
- Subjects that have undergone neuroimaging with identification of intracranial structural pathology.
- Self-reported history of central nervous system injury other than mTBI, or disease (examples will include, but will not be limited to, moderate or severe traumatic brain injury (TBI with a Glasgow Coma Scale \< 13) epilepsy, seizures, brain surgery)
- Neuropsychological disorder such as autistic spectrum disorder
- Any history of a learning disability (examples include, but will not be limited to, dyslexia, dysgraphia, dyscalculia, or a nonverbal learning disorder)
- Use of any medication affecting central nervous system (CNS) in the past 3 months prior to their BNA (i.e. antidepressants, anticonvulsants, psychostimulants, first generation antihistamines, etc.)
- Active head lice infection
- Open scalp wound
- baldness, dread locks or hair that is otherwise sufficiently long and thick so as to preclude appropriate scalp electrode cap fit
- Deafness, and/or blindness
Key Trial Info
Start Date :
July 5 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03249675
Start Date
July 5 2017
End Date
January 1 2019
Last Update
September 28 2018
Active Locations (1)
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1
The Sports Neurology Clinic at The CORE Institute
Brighton, Michigan, United States, 48114