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Rhythmic sound may retrain the brain to walk better after TBI

NCT ID NCT07702513

Symptom relief Sponsor: Craig Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study tests whether a home-based device that uses rhythmic music to guide walking can help adults with moderate to severe traumatic brain injury improve their mobility, balance, and overall recovery. Participants use the MR-001 device at home for 30 minutes, three times a week for eight weeks, while researchers measure walking speed, balance, mood, and brain activity. The goal is to see if this approach is safe, enjoyable, and effective enough to support long-term recovery outside of a clinic.

What this could mean

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

Active substance
a home-based rhythmic auditory stimulation device called MR-001
What this could lead to
If it works, this could offer a convenient, music-guided way to improve mobility and balance after traumatic brain injury, potentially aiding long-term recovery at home.
What could go wrong
This is a small pilot study with only 33 participants, so results may not apply broadly. The device may not lead to meaningful improvements, and home use could pose safety or adherence challenges.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 33 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. have a moderate to severe TBI that required inpatient rehabilitation; 2. able to ambulate independently, with or without an assistive device.; 3. ambulating \< 1.4 m/s (comfortable walking speed) 4. demonstrate a reciprocal gait pattern; 5. ability to follow directions/standardized instructions; Exclusion Criteria: 1. Uncontrolled cardiopulmonary, metabolic, or infectious disorder; 2. history of orthopedic or additional neurological disorder that limited motor function before TBI; 3. any reason that, in the opinion of the study investigators or medical team, would interfere with completing the study protocol such as behavioral concerns; 4. uncontrolled seizure disorder; 5. participation in any gait interventional trials in last eight weeks; 6. hearing impairment limiting perception of rhythmic cues.

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

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

TBI TBI (traumatic brain injury) Traumatic brain injury Traumatic brain injury | patient

How to take part

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

  1. The places running it

    1 site. 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

  • Craig Hospital

    Englewood, Colorado, 80113, United States

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