Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Concussion Assessment

NCT ID: NCT03265912

Last Updated: 2018-09-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-26
• Study Completion Date: 2018-01-16

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 advances in EEG evoked response potential analysis have led to a novel technique for assessing brain network activation (BNA) patterns. This study purpose is to study this BNA technology in individuals who have sustained a concussion.

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 sport-related concussions occur annually in the United States. Despite ongoing research, there is no highly sensitive clinical test for cognitive function that can be rapidly applied in a sporting environment. This makes the clinical diagnosis of concussion particularly difficult, as the clinical presentation of concussion is highly variable with symptoms often evolving over time. Furthermore, with less than 10% of concussions resulting in loss of consciousness, self-reported symptom presence may be the only initial evidence of a concussion. These factors make concussion a challenging injury to diagnose. Given the variability in concussion presentations, there is no single test that can diagnose a concussion.

ElMindA, the sponsor of this study, has developed a novel method to automatically reveal functional networks of brain activity based on analysis of EEG Event Related Potential (ERP) data. This technological platform is capable of providing new metrics of brain function that can assist in patient evaluation and management. The analysis is done in two separate processes that are entirely separate and are performed independently of one another. Reference Brain Network Models of EEG data were recorded and analyzed from several groups of subjects to establish a set of group patterns that characterized the brain network activity of the group. EEG data from a single subject are processed to enable subject evaluation, as compared to the established group patterns. This individual analysis is the basis of the BNA scores computed for an individual subject.

Therefore, this investigation is designed to evaluate the clinical utility of ElMindA's BNA scores in detecting and managing concussive injuries.

Conditions

Concussion, Mild; TBI (Traumatic Brain Injury); Mild Traumatic Brain Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Mild Traumatic Brain Injury

Subjects enrolled in the GE healthcare study: Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 (mTBI-phase 2), mTBI (Mild Traumatic Brain Injury) patient group also called as Arm 1 in this study.

No interventions assigned to this group

Non Mild Traumatic Brain Injury

Subjects enrolled in the GE healthcare study, Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 (mTBI-phase 2), non-TBI (Non Mild Traumatic Brain Injury) patients also called as Arm 2 in this study.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: collaborator

ElMindA Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital for Special surery

New York, New York, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

ELM-36

Identifier Type: -

Identifier Source: org_study_id