A Pilot Study of Home-Based Rhythmic Auditory Stimulation to Evaluate Mobility, Balance, and Patient-Reported Outcomes After Traumatic Brain Injury

Starting soon · Not applicable

Conditions studied: Traumatic Brain Injury, Traumatic Brain Injury | Patient, TBI, TBI-Traumatic Brain Injury, TBI (Traumatic Brain Injury)

In brief

The goal of this study is to learn whether a home-based rhythmic auditory stimulation (RAS) program using the MR-001 device can help improve walking, balance, and other health outcomes in adults with moderate to severe traumatic brain injury (TBI). The study will also look at how safe and feasible it is for people with TBI to use this device at home. The purpose is to determine the safety, feasibility, and adherence of a home-based, music-guided RAS intervention and to explore preliminary effects on mobility, cognition, mood, enjoyment, perceived change, and cortical excitation. The main questions this study aims to answer are: 1. Does training with the MR-001 device improve walking endurance, gait speed, and balance? 2. Does the intervention improve cognition, mood, fatigue, and participants' impression of change? 3. How enjoyable is the training experience for participants? 4. How does the brain respond to walking with versus without rhythmic auditory stimulation? Researchers will compare the MR-001 intervention to a waitlist control group to see whether the device leads to improvements beyond usual activity. Participants will: 1. Use the MR-001 device at home for 30 minutes, three times per week for eight weeks 2. Complete walking, balance, cognitive, and questionnaire assessments 3. Participate in two lab sessions using functional near-infrared spectroscopy (fNIRS) to measure brain activity during walking 4. Provide two fasting blood samples to measure BDNF, a biomarker related to neuroplasticity 5. Complete study visits at baseline, after eight weeks, and (for the waitlist group) after their treatment period This study will help determine whether a home-based, music-guided walking program can support long-term mobility and recovery after TBI.

Key facts

Study ID

NCT07702513

Run by

Craig Hospital

People needed

33

Starts

2026-07-15

Expected to finish

2028-01-15

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• have a moderate to severe TBI that required inpatient rehabilitation;
• able to ambulate independently, with or without an assistive device.;
• ambulating < 1.4 m/s (comfortable walking speed)
• demonstrate a reciprocal gait pattern;
• ability to follow directions/standardized instructions;

You may not qualify if…

• Uncontrolled cardiopulmonary, metabolic, or infectious disorder;
• history of orthopedic or additional neurological disorder that limited motor function before TBI;
• any reason that, in the opinion of the study investigators or medical team, would interfere with completing the study protocol such as behavioral concerns;
• uncontrolled seizure disorder;
• participation in any gait interventional trials in last eight weeks;
• hearing impairment limiting perception of rhythmic cues.

Where it is running

• Craig Hospital — Englewood, Colorado, United States

Full record on ClinicalTrials.gov

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