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
  Purpose

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.


Condition
Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by ElMindA Ltd:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 146
Study Start Date: February 2012
Study Completion Date: March 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Concussed
Patients with recent concussion
Matched controls
Athletes with no recent concussion

  Eligibility

Ages Eligible for Study:   14 Years to 27 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532271

Locations
United States, Pennsylvania
UPMC Sports Medicine Concussion Program
Pittsburgh, Pennsylvania, United States, 15203
Sponsors and Collaborators
ElMindA Ltd
Investigators
Principal Investigator: Anthony P. Kontos, Ph.D. UPMC Sports Medicine Concussion Program
Principal Investigator: Michael W. Collins, Ph.D. UPMC Sports Medicine Concussion Program
  More Information

No publications provided

Responsible Party: ElMindA Ltd
ClinicalTrials.gov Identifier: NCT01532271     History of Changes
Other Study ID Numbers: ELM-01
Study First Received: February 7, 2012
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by ElMindA Ltd:
mild Traumatic Brain Injury
mTBI
Concussion

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014