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

Summary

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.

Conditions

• Traumatic Brain Injury
• Traumatic Brain Injury | Patient
• TBI
• TBI-Traumatic Brain Injury
• TBI (Traumatic Brain Injury)

Interventions

DEVICE

Home-Based Rhythmic Auditory Stimulation

Participants will complete baseline tests, then be randomly assigned to start training right away or after an eight-week waitlist period. Those in the treatment group will learn to use the MR-001 device and train at home for 30 minutes, three times per week for eight weeks, with weekly check-ins for support and safety. The waitlist group will repeat testing after eight weeks, then complete the same training program. All participants will complete enjoyment surveys, two fNIRS sessions to measure brain activity while walking with and without the device, and two fasting blood draws to measure BDNF levels.

Sponsors & Collaborators

• MedRhythms, Inc.

  collaborator INDUSTRY

• Craig Hospital

  lead OTHER

Principal Investigators

• Candace Tefertiller, PT, DPT, PhD, NCS · Craig Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-15

Primary Completion

2027-07-15

Completion

2028-01-15

FDA Device

Yes

Countries

• United States

Study Locations