Recruiting

RAS

Sponsor:

Johns Hopkins University

Code:

NCT05763732

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Rhythmic Auditory Stimulation (RAS)

Study Details

Brief summary:

Participants will be asked to walk along with the metronome beats (RAS) during the participants' stimulation state (ON or OFF) for four minutes for each state.

The researcher will collect the gait parameters (cadence, velocity, and stride length) of patients before, during, and after RAS in both DBS ON and OFF states.

Using MDS-UPDRS, participants' gait patterns will be collected before and after RAS while both DBS is ON and OFF. Electrophysiological activity (local field potentials, LFPs) will be collected across all stages (pre, during, and post-RAS) of evaluation.

Conditions

Parkinson Disease

Study ID

NCT05763732

Start date

Aug 1, 2023

Status verified date

Apr, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients diagnosed with Parkinson disease (PD) (and)
  • PD patients who implanted Deep Brain Stimulation (DBS) of the subthalamic nucleus (STN) with PerceptTM PC

Exclusion Criteria:

  • Inability or unwillingness to follow directions for study procedures

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Pre RAS

After a 10-minute washout period, participants will receive the participants' optimized stimulation.

1. The participants will undergo assessments to measure gait parameters and patterns during stimulation ON and OFF (Pre-RAS) using the 10-meter walk (during a 2-minute walk) and MDS-UPDRS-III rating scale.
2. Electrophysiological activity (e.g., local field potentials, LFPs) will be collected before assessments.

experimental: During RAS

1. The participants will walk to the metronome beats for four minutes (2 minutes for the same beats as baseline cadence and 2 minutes for 10% faster than baseline cadence) (RAS), and the participants' gait parameters will be recorded.
2. Electrophysiological activity (e.g., local field potentials, LFPs) will be collected.

no intervention: Post RAS

The same assessment as the Pre-RAS will be conducted (Post-RAS).

Interventions

Rhythmic Auditory Stimulation (RAS)

Rhythmic auditory stimulus (RAS) is a Neurologic Music Therapy (NMT) technique that utilizes an auditory rhythmic cue to entrain gait to a specific rhythm.

RAS, as an anticipatory time cue, can be used as both an immediate entrainment stimulus, providing rhythmic cues during movement, and as a facilitating stimulus for planning and executing a movement to achieve more functional gait patterns. Cadence, gait velocity, and stride length are the commonly used parameters to monitor changes in a patient's gait.

Primary outcome measure

  • Change in gait cadence (steps/minute) [ Time Frame: 0 minute (Baseline 1, DBS ON), 5 minutes, 10 minutes, 20 minutes (Baseline 2, DBS OFF), 25 minutes, and 30 minutes ]
  • Change in gait velocity (meter/minute) [ Time Frame: 0 minute (Baseline 1, DBS ON), 5 minutes, 10 minutes, 20 minutes (Baseline 2, DBS OFF), 25 minutes, and 30 minutes ]
  • Change in gait stride length (meter) [ Time Frame: 0 minute (Baseline 1, DBS ON), 5 minutes, 10 minutes, 20 minutes (Baseline 2, DBS OFF), 25 minutes, and 30 minutes ]
  • Changes in MDS-UPDRS-III (section 3.9. Arising From Chair ) score [ Time Frame: 0 minute (Baseline 1, DBS ON), 10 minutes, 20 minutes (Baseline 2, DBS OFF), 30 minutes ]
  • Change in MDS-UPDRS-III (section 3.10. Gait) score [ Time Frame: 0 minute (Baseline 1, DBS ON), 10 minutes, 20 minutes (Baseline 2, DBS OFF), 30 minutes ]
  • Change in MDS-UPDRS-III (section 3.11. Freezing of gait) score [ Time Frame: 0 minute (Baseline 1, DBS ON), 10 minutes, 20 minutes (Baseline 2, DBS OFF), 30 minutes ]
  • Change in MDS-UPDRS-III (section 3.12. Postural stability) score [ Time Frame: 0 minute (Baseline 1, DBS ON), 10 minutes, 20 minutes (Baseline 2, DBS OFF), 30 minutes ]
  • Change in MDS-UPDRS-III (section 3.13. Posture) score [ Time Frame: 0 minute (Baseline 1, DBS ON), 10 minutes, 20 minutes (Baseline 2, DBS OFF), 30 minutes ]

Central Contacts and Locations

Central contacts

Alexander Pantelyat, MD

4105023290apantel1@jhmi.edu

Kyurim Kang, Ph.D.

kkang19@jhmi.edu

Locations

Johns Hopkins School of Medicine

Recruiting

Baltimore, Maryland, United States, 21205

More Information

Sponsor

Johns Hopkins University

Last update posted

May 6, 2026

Last verified

Apr, 2026

Keywords

  • Parkinson disease
  • Deep brain stimulation
  • Rhythmic auditory stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-05-06.