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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01532271

Enrollment

151

Registered

2012-02-14

Start date

2012-02-29

Completion date

2014-03-31

Last updated

2019-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

mild Traumatic Brain Injury, mTBI, Concussion

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

14 Years to 27 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results