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

Part of paid clinical trials in Englewood, Colorado.

Sponsor
Craig Hospital
Study ID
NCT07702513
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Home-Based Rhythmic Auditory Stimulation — DEVICE
    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.

Study Details

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 Dates

First listed
Jul 14, 2026
Start date
Jul 15, 2026
Status verified
Jul 2026
Primary completion
Jul 15, 2027
Completion
Jan 15, 2028

Study Design

Enrollment
33 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention
    8 week intervention, 8 week no intervention
  • Active Comparator: Waitlist
    8 week no intervention, 8 week intervention

Primary Outcome Measure

Frequency counts and percentages will be used to summarize the number of adverse events, and participant's session completion and dropout rate [ Time Frame: Immediately after the intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Craig HospitalEnglewoodColorado80113
Marissa Lundstern Research Department
[email protected]
3037898970

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By research site
Craig Hospital· Englewood, CO

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