A Pilot Study of Home-Based Rhythmic Auditory Stimulation to Evaluate Mobility, Balance, and Patient-Reported Outcomes After Traumatic Brain Injury
Public ClinicalTrials.gov record NCT07702513. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Pilot Randomized Waitlist-Controlled Study of Home-Based Rhythmic Auditory Stimulation to Evaluate Mobility, Balance, and Patient-Reported Outcomes After Traumatic Brain Injury
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07702513
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 33 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 14, 2026
- Primary completion
- Jul 14, 2027
- Completion
- Jan 14, 2028
- Last update posted
- Jul 13, 2026
2026 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Craig Hospital | Englewood | Colorado | 80113 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07702513, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 13, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07702513 live on ClinicalTrials.gov.