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Search / Trial NCT03710109

Evaluation of an EEG Based Concussion System

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Oct 15, 2018

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Concussion Sports Concussion Sports Medicine Electroencephalography Steady State Visual Evoked Potential Evoked Potential

ClinConnect Summary

This clinical trial is studying a new device designed to help detect concussions more accurately. The device works by measuring brain activity through a method called electroencephalography (EEG) when a light is flashed in a person's eyes. Researchers want to see how well this device's results match the conclusions made by doctors during standard concussion evaluations. The goal is to develop a helpful tool that can guide people on whether they need to seek medical attention after a head injury.

To participate in this study, individuals should be seeking medical care for a possible concussion at Mount Sinai Hospital or the Play Safe Concussion Clinic. Healthy individuals without any recent head trauma can also be included to compare their results. Participants will receive the usual medical assessments from doctors, along with an evaluation using the new device. It’s important to note that the device is not yet approved by the FDA, but it is considered low-risk and is not intended to replace a doctor's evaluation.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Individuals seeking medical care Mount Sinai Hospital after sustaining a possible concussion.
  • Healthy Individuals with no recent history of head trauma
  • Exclusion Criteria:
  • Known history of epilepsy or any other seizure disorder
  • Legally blind
  • Reduced capacity to consent if there is not a Legally Authorized Representative (LAR) present

About Icahn School Of Medicine At Mount Sinai

The Icahn School of Medicine at Mount Sinai is a premier academic institution located in New York City, renowned for its commitment to advancing medical research, education, and patient care. As a leading sponsor of clinical trials, the institution leverages its state-of-the-art facilities and multidisciplinary expertise to drive innovative research initiatives aimed at improving health outcomes. With a focus on translational medicine, the Icahn School of Medicine collaborates with a diverse network of researchers, clinicians, and industry partners to explore novel therapies and interventions across a wide range of medical disciplines. Its rigorous scientific approach and dedication to ethical standards position it as a trusted leader in the clinical research landscape.

Locations

New York, New York, United States

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

David Putrino, PT, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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