Comparison of Brain Network Activation (BNA™) Analysis, Clinical Symptoms and Neuro-cognitive Performance in Concussed Children and Young Adults
Completed
Conditions studied: Traumatic Brain Injury
In brief
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.
Key facts
- Study ID
- NCT01532271
- Run by
- ElMindA Ltd
- People needed
- 151
- Starts
- 2012-02-01
- Expected to finish
- 2014-03-01
- Last updated by the study team
- 2019-09-25
Who can join
Age: 14 and older, up to 27. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- UPMC Sports Medicine Concussion Program — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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