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CompletedNCT01532271Updated Sep 25, 2019

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

An observational study in Traumatic Brain Injury, sponsored by ElMindA Ltd. Completed at 1 site in United States. Open to participants aged 14 Years to 27 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-25.

Sponsored by ElMindA Ltd · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
151
Ages
14 Years to 27 Years
Sex
All
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Study 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.

02

Conditions studied

  • Traumatic Brain Injury

Keywords

  • mild Traumatic Brain Injury
  • mTBI
  • Concussion
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In context

Brain Injuries, Traumatic

1,818 studies on the registry are indexed under Brain Injuries, Traumatic; 460 are open to participants now.

This study's enrollment of 151 is above the median of 119 across 579 observational studies indexed under Brain Injuries, Traumatic.

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Lead sponsor

ElMindA Ltd is the lead sponsor of 20 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 27 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
151 participants (actual)

Groups and cohorts

  • Concussed

    Patients with recent concussion

  • Matched controls

    Athletes with no recent concussion

06

What researchers measure

Primary outcomes

  1. Change of Brain Network Activation(BNA™)Scores Over Post Concussion Recovery Period

    Time frame: days 2-10, 7-19, 12-28, 17-37 following concussion

Secondary outcomes

  1. Correlation Of The Change In BNA™ Scores To Neurocognitive Tests Scores and Clinical Diagnostic

    Time frame: days 2-10, 7-19, 12-28, 17-37 following concussion

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Study locations

1 site
  • UPMC Sports Medicine Concussion Program
    Pittsburgh, Pennsylvania 15203, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01532271
Lead sponsor
ElMindA Ltd
Responsible party
Sponsor
First posted
Feb 14, 2012
Start date
Feb 2012
Primary completion
Jan 2014
Completion
Mar 2014
Last update
Sep 25, 2019

Study contacts

Anthony P. Kontos, Ph.D.
principal investigator · UPMC Sports Medicine Concussion Program
Michael W. Collins, Ph.D.
principal investigator · UPMC Sports Medicine Concussion Program

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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