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New device aims to take the guesswork out of concussion recovery

NCT ID NCT07190963

Diagnosis Sponsor: MindRhythm, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study is testing a device called HeadPulse that monitors brain signals to see if it can objectively detect when a concussion has fully resolved. Researchers are enrolling 150 people aged 4 and older, mostly athletes, who have had a concussion. The goal is to develop a tool that can tell coaches, doctors, and parents when it is truly safe to return to sports or normal activities, even if the person feels fine.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HeadPulse device (digital biometric monitor)
What this could lead to
If successful, this device could provide an objective way to know when a person has fully recovered from a concussion, reducing the risk of returning to activity too soon.
What could go wrong
This is an early observational study with only 150 participants, so results may not apply to everyone. The device is still being validated and may not be accurate for all ages or injury types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

4 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: An individual who has been diagnosed with or suspected to have a concussion or mTBI. \- Exclusion Criteria: open wounds on the head. Pregnant women due to unexpected risks. Subjects under the age of 4. \-

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Conditions

The condition(s) this trial relates to.

Brain Concussion traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mtbi - mild traumatic brain injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • MindRhythm Incorporated

    ENROLLING_BY_INVITATION

    Cupertino, California, 95014, United States

  • MindRhythm Incorporated

    RECRUITING

    Cupertino, California, 95014, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.