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NCT01535339 · ClinicalTrials.gov registry record

Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Sport Concussion Assessment - Test Stability and Effect of Concussion

A clinical trial, sponsored by ElMindA.

Completed
Registry status
109
Enrollment target

NCT01535339: Completed study, sponsored by ElMindA.

NCT01535339 is a clinical trial that has completed, run by ElMindA. The registered enrollment target is 109 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01535339 has completed, sponsored by ElMindA.

COMPLETED
Registry status
109 participants
Enrollment target

Study Summary

Mild traumatic brain injury (mTBI), also known as concussion, occurs commonly in sport. Despite ongoing research, there is no highly sensitive clinical test for cognitive function. This makes the clinical diagnosis of concussion particularly difficult as the clinical presentation of concussion is highly variable with symptoms often evolving over time. Given the variability in concussion presentations, there is no single test that can diagnose a concussion. Current recommendations are that sports medicine providers apply a multifaceted concussion assessment battery that combines subjective symptoms, motor control and cognitive assessment. This investigation is designed to evaluate the clinical utility of ElMindA's BNA scores in detecting and managing concussive injuries. This study will establish the reliability of BNA™ scores over clinically relevant assessment intervals and investigate the effect of SRC and sub-concussive head impacts on BNA scores.

Trial Details

FieldValue
Enrollment Target 109 participants
Start Date 2012-02
Est. Completion 2015-12
ElMindA

12 total trials

What the finished NCT01535339 record still lists

NCT01535339 is an observational study that tracks outcomes without assigning an intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT01535339 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01535339 about?

NCT01535339 is a clinical study titled "Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Sport Concussion Assessment - Test Stability and Effect of Concussion". Mild traumatic brain injury (mTBI), also known as concussion, occurs commonly in sport. Despite ongoing research, there is no highly sensitive clinical test for cognitive function. This makes the clinical diagnosis of concussion particularly difficult as the clinical presentation of concussion is hi...

What is the current status of trial NCT01535339?

This trial is currently completed. The enrollment target is 109 participants. The study started on 2012-02. Estimated completion is 2015-12.

Who is sponsoring clinical trial NCT01535339?

This trial is sponsored by ElMindA, which has 12 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01535339, the US trial registry maintained by the National Library of Medicine. NCT01535339 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.