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

NCT03265912 | Completed

• 1 other identifier: ELM-36
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Assess the BNA database for Mild Traumatic Brain Injury and Non Mild Traumatic Brain Injury population.

  Functional networks of brain activity is measured using analysis of EEG Event Related Potential (ERP) data. Clinical assessments battery will be utilized in order to examine different sets of BNA database for Mild Traumatic Brain Injury and Non Mild Traumatic Brain Injury population.

  This study duration is 12 months

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents, young adults and adults of both genders, enrolled in Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 (mTBI-phase2) Age range: 15-50 years

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• ElMindA Ltd: lead
• GE Healthcare: collaborator

Study Sites (2)

Hospital for Special surery

New York, New York, 10021, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Brain Concussion; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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 Design

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

Study Record Dates

• First Submitted: August 20, 2017
• First Posted: August 29, 2017
• Study Start: January 26, 2017
• Primary Completion: January 16, 2018
• Study Completion: January 16, 2018
• Last Updated: September 27, 2018

Record last verified: 2018-09

Locations

US (2)