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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01532271
Other study ID # ELM-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2012
Est. completion date March 2014

Study information

Verified date September 2019
Source ElMindA Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 151
Est. completion date March 2014
Est. primary completion date January 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 27 Years
Eligibility 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

Study Design


Locations

Country Name City State
United States UPMC Sports Medicine Concussion Program Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
ElMindA Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of Brain Network Activation(BNA™)Scores Over Post Concussion Recovery Period days 2-10, 7-19, 12-28, 17-37 following concussion
Secondary 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
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