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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03710109
Other study ID # GCO 18-0699
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 23, 2018
Est. completion date July 2024

Study information

Verified date November 2023
Source Icahn School of Medicine at Mount Sinai
Contact Aidan Rogers, MS
Phone 212-824-8369
Email aidan.rogers@mountsinai.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will evaluate the accuracy of a new concussion system at detecting concussions. The investigators will be evaluating the degree to which data collected with the device agrees with a physician's determination of a concussion. The system captures an electroencephalograph (EEG) potential when a light is flashed into the eyes of an individual. The device is not FDA approved, but it is a non-significant risk device. The device is a non-invasive, non-interventional sensor. It will not replace the opinion of the physician in diagnosing a concussion. This study will test the EEG based concussion system on 200 individuals, Participants will be made up of individuals who are seeking medical consultation at the Play Safe Concussion Clinic (10 Union Square E, New York, NY 10003) or at Mount Sinai Hospital (1468 Madison Ave, New York, NY 10029) after experiencing a head trauma. The Play Safe Clinic treats patients who reach out to Mount Sinai Physicians via the Play Safe telephone number: 212 241 2221. The doctors who see patients these locations will be involved in conducting this research. In addition to the standard-of-care clinical assessments, participants will also receive an evaluation from the concussion based system. When a subject experiences a head trauma, the subject will be evaluated for a concussion by both the standard-of-care clinical assessments. The treating physician will provide all necessary standard-of-care evaluations and diagnostic procedures needed to properly diagnose and treat each patient and by the new concussion system. The researchers will also collect data from healthy, age-matched controls in order to collect a database of healthy responses to the technology. To determine how accurate the new concussion system is at detecting concussions, the research team will compare the diagnostic results from the device to the diagnostic results of the doctor's assessments. The goal of this study is to develop a device that can give sound advice as to whether an individual should seek medical attention for a possible concussion following a head injury.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers
Gender All
Age group 9 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
EEG
non-invasive, non-interventional sensor

Locations

Country Name City State
United States Abilities Research Center New York New York
United States Mount Sinai Beth Israel Hospital New York New York

Sponsors (1)

Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Steady State Visual Evoked Potential the presence or absence of a steady state visual evoked potential (SSVEP) up to 28 days
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