Traumatic Brain Injury Clinical Trial
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
| NCT number | NCT01532271 |
| Other study ID # | ELM-01 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 2012 |
| Est. completion date | March 2014 |
| Verified date | September 2019 |
| Source | ElMindA Ltd |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 151 |
| Est. completion date | March 2014 |
| Est. primary completion date | January 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 14 Years to 27 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | UPMC Sports Medicine Concussion Program | Pittsburgh | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| ElMindA Ltd |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change of Brain Network Activation(BNA™)Scores Over Post Concussion Recovery Period | days 2-10, 7-19, 12-28, 17-37 following concussion | ||
| Secondary | 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 |
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