NCT05763732 · Johns Hopkins University
Effects of RAS on Gait in PD Patients With DBS
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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 measures
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
Gait cadence will be calculated with a 10-meter walk. Cadence (steps/min) = 60 / time (seconds) x # of steps
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
Gait velocity will be calculated with a 10-meter walk. Velocity(meter/min) = 60 / time (seconds) x 10 meter
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
Gait stride length will be calculated with a 10-meter walk. Stride length (meter) = Velocity / Cadence x 2
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
0: Normal: No problems. Able to arise quickly without hesitation. 1. Slight: Arising is slower than normal; or may need more than one attempt; or may need to move forward in the chair to arise. No need to use the arms of the chair. 2. Mild: Pushes self up from the arms of the chair without difficulty. 3. Moderate: Needs to push off, but tends to fall back; or may have to try more than one time using the arms of the chair, but can get up without help. 4. Severe: Unable to arise without help.
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
0: Normal: No problems. 1. Slight: Independent walking with minor gait impairment. 2. Mild: Independent walking but with substantial gait impairment. 3. Moderate: Requires an assistance device for safe walking (walking stick, walker) but not a person. 4. Severe: Cannot walk at all or only with another person's assistance.
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
0: Normal: No freezing. 1. Slight: Freezes on starting, turning, or walking through doorway with a single halt during any of these events, but then continues smoothly without freezing during straight walking. 2. Mild: Freezes on starting, turning, or walking through doorway with more than one halt during any of these activities, but continues smoothly without freezing during straight walking. 3. Moderate: Freezes once during straight walking. 4. Severe: Freezes multiple times during straight walking.
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
0: Normal: No problems. Recovers with one or two steps. 1. Slight: 3-5 steps, but subject recovers unaided. 2. Mild: More than 5 steps, but subject recovers unaided. 3. Moderate: Stands safely, but with absence of postural response; falls if not caught by examiner. 4. Severe: Very unstable, tends to lose balance spontaneously or with just a gentle pull on the shoulders.
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
0: Normal: No problems. 1. Slight: Not quite erect, but posture could be normal for older person. 2. Mild: Definite flexion, scoliosis or leaning to one side, but patient can correct posture to normal posture when asked to do so. 3. Moderate: Stooped posture, scoliosis or leaning to one side that cannot be corrected volitionally to a normal posture by the patient. 4. Severe: Flexion, scoliosis or leaning with extreme abnormality of posture.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Baltimore, Maryland
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Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations