Clinical trial NCT01532271: Comparison of Brain Network Activation (BNA™) Analysis, Clinical Symptoms and Neuro-cognitive Performance in Concussed Children and Young Adults
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: mild Traumatic Brain Injury
mTBI
Concussion
Lead sponsor: ElMindA Ltd
Sponsor class: INDUSTRY
First posted: 2012-02-14
Enrollment: 151
Sex: ALL
Minimum age (years): 14
Maximum age (years): 27
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Experimental subjects will include males and females with a recent sports-related concussion (less than 10 days post-concussion) recruited from approximately 50 high schools and colleges with UPMC-affiliated certified athletic trainers (ATC) on staff and from patients at the UPMC Sports Medicine Concussion Program.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of Brain Network Activation(BNA™)Scores Over Post Concussion Recovery Period
timeFrame: days 2-10, 7-19, 12-28, 17-37 following concussion
Secondary outcomes:
measure: Correlation Of The Change In BNA™ Scores To Neurocognitive Tests Scores and Clinical Diagnostic
timeFrame: days 2-10, 7-19, 12-28, 17-37 following concussion
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Sports Medicine Concussion Program
state: Pennsylvania
Study officials:
affiliation: UPMC Sports Medicine Concussion Program
name: Anthony P. Kontos, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: UPMC Sports Medicine Concussion Program
name: Michael W. Collins, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: