RECRUITING

Evaluation of an EEG Based Concussion System

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluation of an EEG Based Concussion System

Quick Facts

Study Start:2018-10-23
Study Completion:2024-12-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03710109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:9 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals seeking medical care Mount Sinai Hospital after sustaining a possible concussion.
  2. * Healthy Individuals with no recent history of head trauma
  1. * Known history of epilepsy or any other seizure disorder
  2. * Legally blind
  3. * Reduced capacity to consent if there is not a Legally Authorized Representative (LAR) present

Contacts and Locations

Study Contact

Aidan Rogers, MS
CONTACT
212-824-8369
aidan.rogers@mountsinai.org

Principal Investigator

David Putrino, PT, PhD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Mount Sinai Beth Israel Hospital
New York, New York, 10003
United States
Abilities Research Center
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • David Putrino, PT, PhD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-10-23
Study Completion Date2024-12-20

Study Record Updates

Study Start Date2018-10-23
Study Completion Date2024-12-20

Terms related to this study

Keywords Provided by Researchers

  • Concussion
  • Sports Concussion
  • Sports Medicine
  • Electroencephalography
  • Steady state visual evoked potential
  • Evoked Potential

Additional Relevant MeSH Terms

  • Concussion