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

NCT01532271 | Completed

• 1 other identifier: ELM-01
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Traumatic Brain Injury

Keywords

mild Traumatic Brain Injury; mTBI; Concussion

Outcome Measures

Primary Outcomes (1)

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

  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

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

Study Arms (2)

Concussed

Patients with recent concussion

Matched controls

Athletes with no recent concussion

Eligibility Criteria

• Age: 14 Years - 27 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• ElMindA Ltd: lead

Study Sites (1)

UPMC Sports Medicine Concussion Program

Pittsburgh, Pennsylvania, 15203, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Anthony P. Kontos, Ph.D.

  UPMC Sports Medicine Concussion Program

  PRINCIPAL INVESTIGATOR

• Michael W. Collins, Ph.D.

  UPMC Sports Medicine Concussion Program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2012
• First Posted: February 14, 2012
• Study Start: February 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: March 1, 2014
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

US (1)