MindRhythm Detection of Concussion and Recovery Study

NCT07190963 | Recruiting

• 1 other identifier: mTBI-002MR
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

mTBI - Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is measurement and aggregate evaluation of the time course of HeadPulse abnormalities and the proportion of subjects who later worsen following clearance to return to activities.

  Subject data will be acquired for approximately 30 days from subject enrollment

Study Arms (2)

Concussed

An individual who is diagnosed or suspected of having a mTBI or concussion

Normal

An individual who has not been diagnosed or suspected of having a mTBI or concussion within one preceding year

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who have experienced a mTBI/concussion compared to a cohort of cohort of neurologically normal individuals who have not experienced diagnosed or undiagnosed concussion or head trauma within the last 12 months.

Sponsors & Collaborators

• MindRhythm, Inc.: lead

Study Sites (2)

MindRhythm Incorporated

Cupertino, California, 95014, United States

ENROLLING BY INVITATION

MindRhythm Incorporated

Cupertino, California, 95014, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Central Study Contacts

Beth Johnson-Reich

CONTACT

8608368630; beth.johnson@mindrhythm.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: September 24, 2025
• Study Start: January 28, 2025
• Primary Completion (Estimated): January 28, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

US (2)