Comparison of Brain Network Activation (BNA™) Analysis, Clinical Symptoms and Neuro-cognitive Performance in Concussed Children and Young Adults

Completed

• Conditions: Traumatic Brain Injury

• Registration Number: NCT01532271
• Lead Sponsor: ElMindA Ltd

Brief Summary

The use of Event Related Potentials (ERP) and neurocognitive performance in patients following concussion has been examined previously in small cohorts and relatively long after concussion occurred. However, little is known about the immediate changes in brain activity in specific brain regions and connectivity across them associated with performance on specific neurocognitive tests following a concussion, and the subsequent changes over time. The proposed study will provide initial evidence for the feasibility of an ERP based biomarker for concussion reflecting temporal and spatial changes in brain activity as well as brain functional connectivity associated with concussion.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-07
• Study First Submitted QC: 2012-02-09
• Study First Posted: 2012-02-14
• Primary Completion: 2014-01
• Study Completion: 2014-03
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-23
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

• Aged 14-27 years
• Arm 1 only (Concussed): Over 2 days and below 10 days post-concussion (sports-related)
• Currently symptomatic
• Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self)

Exclusion Criteria

• TBI (i.e., Glasgow Coma Scale <13) or brain surgery
• Any psychiatric disorder
• Substance abuse
• Special education
• Any Neurological disorder
• Any medication affecting CNS
• Significant sensory deficits such as deafness or blindness
• Clinically significant abnormal laboratory values or ECG
• A history of more than 3 concussions in the past
• A concussion within the last year
• Residual symptoms or deficits related to a previous concussion

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of Brain Network Activation(BNA™)Scores Over Post Concussion Recovery Period	days 2-10, 7-19, 12-28, 17-37 following concussion

Secondary Outcome Measures

Name	Time	Method
Correlation Of The Change In BNA™ Scores To Neurocognitive Tests Scores and Clinical Diagnostic	days 2-10, 7-19, 12-28, 17-37 following concussion

Trial Locations

Locations (1)

UPMC Sports Medicine Concussion Program; 🇺🇸 Pittsburgh, Pennsylvania, United States