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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ElMindA Ltd
ClinicalTrials.gov Identifier:
NCT01532271
First received: February 7, 2012
Last updated: April 3, 2014
Last verified: April 2014

February 7, 2012
April 3, 2014
February 2012
January 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Change of Brain Network Activation(BNA™)Scores Over Post Concussion Recovery Period [ Time Frame: days 3, 10, 17, 24, 90 following concussion ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01532271 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Correlation Of The Change In BNA™ Scores To Neurocognitive Tests Scroes and Clinical Diagnstic [ Time Frame: days 3, 10, 17, 24, 90 following concussion ] [ Designated as safety issue: Yes ]
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Not Provided
 
Comparison of Brain Network Activation (BNA™) Analysis, Clinical Symptoms and Neuro-cognitive Performance in Concussed Children and Young Adults
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Traumatic Brain Injury
Not Provided
  • Concussed
    Patients with recent concussion
  • Matched controls
    Athletes with no recent concussion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
146
March 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
14 Years to 27 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01532271
ELM-01
No
ElMindA Ltd
ElMindA Ltd
Not Provided
Principal Investigator: Anthony P. Kontos, Ph.D. UPMC Sports Medicine Concussion Program
Principal Investigator: Michael W. Collins, Ph.D. UPMC Sports Medicine Concussion Program
ElMindA Ltd
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP