Evaluating a new EEG system for detecting concussions
Evaluation of an EEG Based Concussion System
Icahn School of Medicine at Mount Sinai · NCT03710109
This study is testing a new device that uses brain wave patterns to see if it can accurately detect concussions in people who have had head injuries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 9 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai (other) |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT03710109 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the accuracy of a novel EEG-based concussion detection system by comparing its results with physician diagnoses of concussion. The system captures electroencephalographic data in response to visual stimuli and is designed to be a non-invasive tool for concussion assessment. The study will involve 200 participants who have experienced head trauma and are seeking medical consultation at designated clinics in New York. Although the device is not FDA approved, it is classified as a non-significant risk device and will not replace physician evaluations.
Who should consider this trial
Good fit: Ideal candidates include individuals seeking medical care for potential concussions at the specified clinics.
Not a fit: Patients with a known history of epilepsy or other seizure disorders, or those who are legally blind, may not benefit from this study.
Why it matters
Potential benefit: If successful, this system could provide a more accurate and objective method for diagnosing concussions.
How similar studies have performed: While this approach is innovative, similar EEG-based methods for concussion detection have shown promise in preliminary studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York and 1 other locations
- Mount Sinai Beth Israel Hospital — New York, New York, United States (RECRUITING)
- Abilities Research Center — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: David Putrino, PT, PhD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Aidan Rogers, MS
- Email: aidan.rogers@mountsinai.org
- Phone: 212-824-8369
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Concussion, Sports Concussion, Sports Medicine, Electroencephalography, Steady state visual evoked potential, Evoked Potential