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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

14 year–27 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UPMC Sports Medicine Concussion Program

Pittsburgh, Pennsylvania, 15203, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Change of Brain Network Activation(BNA™)Scores Over Post Concussion Recovery Period

Time frame: days 2-10, 7-19, 12-28, 17-37 following concussion

Secondary outcomes

Correlation Of The Change In BNA™ Scores To Neurocognitive Tests Scores and Clinical Diagnostic

Time frame: days 2-10, 7-19, 12-28, 17-37 following concussion

Sponsors and collaborators

Lead sponsor

ElMindA Ltd

Industry

Registry information

Official study title

Comparison of Brain Network Activation Analysis (BNA™) Using Evoked Response Potentials, Clinical Symptoms and Neuro-cognitive Performance and Symptoms in Concussed Children, Young Adults and Matched Controls

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Feb 14, 2012
Registry last updated: Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed