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

E

ElMindA

Status

Completed

Conditions

Traumatic Brain Injury

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

151 patients

Sex

All

Ages

14 to 27 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

151 participants in 2 patient groups

Concussed
Description:
Patients with recent concussion
Matched controls
Description:
Athletes with no recent concussion

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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