Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Concussion Assessment, Young Adults and Adults

Withdrawn before enrolling

Conditions studied: Concussion, Brain

In brief

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 to experience post-concussion syndrome (PCS). In the United States, PCS diagnoses have increased 100% from 2010-2015. Concurrently, recent advances in EEG evoked response potential analysis have led to a novel technique for assessing brain network activation (BNA) patterns. The purpose of this study is to explore the use of BNA in individuals who are diagnosed with PCS or have the risk of experiencing PCS due to a recent injury.

Key facts

Study ID

NCT03249675

Run by

ElMindA Ltd

People needed

0

Starts

2017-07-05

Expected to finish

2019-01-01

Last updated by the study team

2018-09-28

Who can join

Age: 12 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• The Sports Neurology Clinic at The CORE Institute — Brighton, Michigan, United States

Full record on ClinicalTrials.gov

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