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

NCT07702513 | Not Yet Recruiting FDA Device

• 1 other identifier: 2906
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does training with the MR-001 device improve walking endurance, gait speed, and balance?
2. 2.Does the intervention improve cognition, mood, fatigue, and participants' impression of change?
3. 3.How enjoyable is the training experience for participants?
4. 4.How does the brain respond to walking with versus without rhythmic auditory stimulation?
5. 5.Use the MR-001 device at home for 30 minutes, three times per week for eight weeks
6. 6.Complete walking, balance, cognitive, and questionnaire assessments
7. 7.Participate in two lab sessions using functional near-infrared spectroscopy (fNIRS) to measure brain activity during walking
8. 8.Provide two fasting blood samples to measure BDNF, a biomarker related to neuroplasticity
9. 9.Complete study visits at baseline, after eight weeks, and (for the waitlist group) after their treatment period

Conditions

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

Keywords

TBI; Traumatic Brain Injury; Rhythmic Auditory Stimulation; BEAT TBI

Outcome Measures

Primary Outcomes (1)

• Frequency counts and percentages will be used to summarize the number of adverse events, and participant's session completion and dropout rate

  Frequency counts and percentages will be used to summarize the number of adverse events, and participant's session completion and dropout rate to assess for safety, feasibility, and adherence.

  Immediately after the intervention

Secondary Outcomes (5)

• 10MWT

  Baseline, 8 weeks, 16 weeks

• Berg Balance Scale

  Baseline, 8-weeks, 16-weeks

• 6minWT

  Baseline, 8 weeks, 16 weeks

• Functional Gait Assessment (FGA)

  Baseline, 8 week, 16 week

• High-Level Mobility Assessment Tool (HiMAT)

  Baseline, 8 week, 16 week

Other Outcomes (6)

• Brief Test of Adult Cognition by Telephone (BTACT)

  Baseline, 8 weeks, 16 weeks

• Brief Symptom Inventory-18 (BSI 18)

  Baseline, 8 weeks, 16 weeks

• Modified Fatigue Impact Scale (MFIS)

  Baseline, 8 weeks, 16 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

8 week intervention, 8 week no intervention

Device: Home-Based Rhythmic Auditory Stimulation

Waitlist

ACTIVE COMPARATOR

8 week no intervention, 8 week intervention

Device: Home-Based Rhythmic Auditory Stimulation

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.

Also known as: MedRhythms

Intervention; Waitlist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Craig Hospital: lead
• MedRhythms, Inc.: collaborator

Study Sites (1)

Craig Hospital

Englewood, Colorado, 80113, United States

Location

Related Publications (40)

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MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Candace Tefertiller, PT, DPT, PhD, NCS

  Craig Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marissa Lundstern, MPH

CONTACT

3037898970; mlundstern@craighospital.org

Katie Bedell, PT, DPT

CONTACT

3037898456; kbedell@craighospital.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director of Research and Evaluation

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 14, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): January 15, 2028
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)