RECRUITING

MindRhythm Detection of Concussion and Recovery Study

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 is designed to observe HeadPulse data in concussed subjects that may have experienced a concussion via an injury down to the age of 4. Sports teams are the focus of this study because therein lies inherent potential risk for concussion. This observational study will further confirm the data previously collected in professional athletes to further validate that the HeadPulse can be used as a digital biometric to objectively indicate when a concussed brain remains concussed despite a subject feeling no symptoms has extreme value. This study is intended to support the development of a device to objectively determine when it is safe to return to play or normal activity based on the output of the digital biometric.

Official Title

Detection of Concussion and Recovery Study

Quick Facts

Study Start:2025-01-28
Study Completion:2027-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07190963

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:4 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Beth Johnson-Reich
CONTACT
8608368630
beth.johnson@mindrhythm.com

Study Locations (Sites)

MindRhythm Incorporated
Cupertino, California, 95014
United States
MindRhythm Incorporated
Cupertino, California, 95014
United States

Collaborators and Investigators

Sponsor: MindRhythm, Inc.

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 Date2025-01-28
Study Completion Date2027-03-30

Study Record Updates

Study Start Date2025-01-28
Study Completion Date2027-03-30

Terms related to this study

Additional Relevant MeSH Terms

  • mTBI - Mild Traumatic Brain Injury