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

NCT03249675 | Withdrawn

• 1 other identifier: ELM 48
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Concussion, Brain

Keywords

mild Traumatic Brain Injury; Concussion

Outcome Measures

Primary Outcomes (1)

• Developing a BNA database for concuss population.

  Functional networks of brain activity in healthy individuals measured using analysis of EEG Event Related Potential (ERP) data

  This study duration is 18 months

Study Arms (2)

ARM 1

ARM 1: Retrospective Arm: Subjects tested with BNA in the past and have been diagnosed by their physician as having Post Concussive Syndrome. Study staff will contact the subjects and obtain Informed Consent. Study physicians will then review both BNA data and Clinical data. All relevant clinical data and all available BNA data will be shared with ElMindA. Subjects may be invited for an additional BNA follow up as part of the study.

ARM 2

ARM 2: Subjects will be prospectively enrolled in the study at the following time points when available: * Acute: within 2 weeks of injury * PCS: Subjects which sustained a concussion in the past 3 months or more, and are still experiencing symptoms related to the injury

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents, young adults and adults of both genders.

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

Sponsors & Collaborators

• ElMindA Ltd: lead

Study Sites (1)

The Sports Neurology Clinic at The CORE Institute

Brighton, Michigan, 48114, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Jeffrey Kutcher, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 15, 2017
• Study Start: July 5, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: September 28, 2018

Record last verified: 2018-09

Locations

US (1)