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NCT Number: NCT05763732

Effects of RAS on Gait in PD Patients With DBS

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

Location status: Recruiting

Location contact

Alexander Pantelyat, MD

CONTACT

About this study

Given the evidence that rhythmic auditory stimulation (RAS) can modulate beta oscillation and improve gait parameters, the purpose of this study is to examine behavioral and neurophysiological rhythmic entrainment mechanisms.

Participants who complete the consent and enrollment process will remain for an additional up to 1 hour following the participants' routine clinic visit at the Jons Hopkins Outpatient Clinic.

The protocol will consist of two parts (DBS ON and DBS OFF). The order of stimulation states will be randomly assigned to the participants.

During DBS ON, participants will receive the participants' previously optimized stimulation after a 10-minute washout period. The researchers will measure participants' gait parameters (cadence, velocity, and stride length) with a 2-minute walk (a set distance of 10 meters during the 2-minute walk) and gait patterns using relevant items from the MDS-UPDRS-III rating scale during stimulation ON (Pre-RAS).

The participants will then walk to the metronome beats for a total of four minutes (2 minutes for the same beat as baseline cadence and 2 minutes for 10% faster than baseline cadence) (RAS), and the gait parameters will be recorded. The order of the tempo will be randomized across the participants.

Finally, after this 4-minute walk, the same assessment as for Pre-RAS will be conducted (Post-RAS).

Electrophysiological activity (local field potentials, LFPs) will be collected across all stages (pre, during, and post-RAS) of evaluation.

In DBS OFF, there will be a separate 10-minute washout period if it is taking place after DBS ON so that the participant's brain circuits can adjust to not being stimulated. Except for the DBS stimulation state, DBS OFF will follow the same protocol as DBS ON above.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rhythmic Auditory Stimulation (RAS)

Behavioral

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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

    • 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.
    • Mild: Pushes self up from the arms of the chair without difficulty.
    • 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.
    • Severe: Unable to arise without help.

  5. 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.

    • Slight: Independent walking with minor gait impairment.
    • Mild: Independent walking but with substantial gait impairment.
    • Moderate: Requires an assistance device for safe walking (walking stick, walker) but not a person.
    • Severe: Cannot walk at all or only with another person's assistance.

  6. 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.

    • 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.
    • 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.
    • Moderate: Freezes once during straight walking.
    • Severe: Freezes multiple times during straight walking.

  7. 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.

    • Slight: 3-5 steps, but subject recovers unaided.
    • Mild: More than 5 steps, but subject recovers unaided.
    • Moderate: Stands safely, but with absence of postural response; falls if not caught by examiner.
    • Severe: Very unstable, tends to lose balance spontaneously or with just a gentle pull on the shoulders.

  8. 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.

    • Slight: Not quite erect, but posture could be normal for older person.
    • Mild: Definite flexion, scoliosis or leaning to one side, but patient can correct posture to normal posture when asked to do so.
    • Moderate: Stooped posture, scoliosis or leaning to one side that cannot be corrected volitionally to a normal posture by the patient.
    • Severe: Flexion, scoliosis or leaning with extreme abnormality of posture.

Secondary outcomes

  1. Change in power spectrum density of Local Fields Potential (LFP) (micro-volts-squared per Hz)

    Time frame: 0 minute (Baseline 1, DBS ON), 5 minutes, 10 minutes, 20 minutes (Baseline 2, DBS OFF), 25 minutes, and 30 minutes

    Power spectrum density will show the strength of the variations (energy) as a function of frequency. In other words, it shows at which frequencies variations are strong and at which frequencies variations are weak.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Pantelyat, MD

CONTACT

[email protected]

4105023290

Kyurim Kang, Ph.D.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Effects of Rhythmic Auditory Stimulation (RAS) on Gait in Parkinson Disease (PD) Patients With DBS

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Mar 10, 2023
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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