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Parkinson DiseaseNCT05763732

Effects of RAS on Gait in PD Patients With DBS

A study testing Rhythmic Auditory Stimulation (RAS) in people with Parkinson Disease, run by Johns Hopkins University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Parkinson Disease
What is being tested?
Rhythmic Auditory Stimulation (RAS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
1 Aug 2023to 30 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Inability or unwillingness to follow directions for study procedures

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alexander Pantelyat, MD contact

4105023290

apantel1@jhmi.edu

Kyurim Kang, Ph.D. contact

kkang19@jhmi.edu

United States1 site, 1 recruiting
  • Johns Hopkins School of Medicine

    Baltimore, Maryland, 21205

    Alexander Pantelyat, MD

    Recruiting

Other trials in United States

About this study

Official title: Effects of Rhythmic Auditory Stimulation (RAS) on Gait in Parkinson Disease (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.

Read the detailed description

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.

Being tested
Rhythmic Auditory Stimulation (RAS)
Keywords
Parkinson disease, Deep brain stimulation, Rhythmic auditory stimulation
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rhythmic Auditory Stimulation (RAS)Behavioural

    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.

Study groups in NCT05763732
Study groupRoleWhat they receive
Pre RASNo interventionAfter 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.
During RASExperimental1. 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.
Receives: Behavioral: Rhythmic Auditory Stimulation (RAS)
Post RASNo interventionThe same assessment as the Pre-RAS will be conducted (Post-RAS).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in gait cadence (steps/minute)

    Gait cadence will be calculated with a 10-meter walk.

    Cadence (steps/min) = 60 / time (seconds) x # of steps

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

  2. Change in gait velocity (meter/minute)

    Gait velocity will be calculated with a 10-meter walk.

    Velocity(meter/min) = 60 / time (seconds) x 10 meter

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

  3. Change in gait stride length (meter)

    Gait stride length will be calculated with a 10-meter walk.

    Stride length (meter) = Velocity / Cadence x 2

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

  4. Changes in MDS-UPDRS-III (section 3.9. Arising From Chair ) score

    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.

    Measured: 0 minute (Baseline 1, DBS ON), 10 minutes, 20 minutes (Baseline 2, DBS OFF), 30 minutes

  5. Change in MDS-UPDRS-III (section 3.10. Gait) score

    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.

    Measured: 0 minute (Baseline 1, DBS ON), 10 minutes, 20 minutes (Baseline 2, DBS OFF), 30 minutes

  6. Change in MDS-UPDRS-III (section 3.11. Freezing of gait) score

    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.

    Measured: 0 minute (Baseline 1, DBS ON), 10 minutes, 20 minutes (Baseline 2, DBS OFF), 30 minutes

  7. Change in MDS-UPDRS-III (section 3.12. Postural stability) score

    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.

    Measured: 0 minute (Baseline 1, DBS ON), 10 minutes, 20 minutes (Baseline 2, DBS OFF), 30 minutes

  8. Change in MDS-UPDRS-III (section 3.13. Posture) score

    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.

    Measured: 0 minute (Baseline 1, DBS ON), 10 minutes, 20 minutes (Baseline 2, DBS OFF), 30 minutes

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

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2023
  2. Study start1 Aug 2023
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05763732
Sponsor's protocol ID
IRB00374716
Status last verified
Apr 2026
First submitted
28 Feb 2023
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fujioka T, Ross B, Trainor LJ. Beta-Band Oscillations Represent Auditory Beat and Its Metrical Hierarchy in Perception and Imagery. J Neurosci. 2015 Nov 11;35(45):15187-98. doi: 10.1523/JNEUROSCI.2397-15.2015.

    PubMed 26558788
  • Naro A, Pignolo L, Sorbera C, Latella D, Billeri L, Manuli A, Portaro S, Bruschetta D, Calabro RS. A Case-Controlled Pilot Study on Rhythmic Auditory Stimulation-Assisted Gait Training and Conventional Physiotherapy in Patients With Parkinson's Disease Submitted to Deep Brain Stimulation. Front Neurol. 2020 Aug 4;11:794. doi: 10.3389/fneur.2020.00794. eCollection 2020.

    PubMed 32849240
  • Fujioka T, Trainor LJ, Large EW, Ross B. Beta and gamma rhythms in human auditory cortex during musical beat processing. Ann N Y Acad Sci. 2009 Jul;1169:89-92. doi: 10.1111/j.1749-6632.2009.04779.x.

    PubMed 19673759
  • Jimenez-Shahed J. Device profile of the percept PC deep brain stimulation system for the treatment of Parkinson's disease and related disorders. Expert Rev Med Devices. 2021 Apr;18(4):319-332. doi: 10.1080/17434440.2021.1909471. Epub 2021 Apr 5.

    PubMed 33765395
  • Gilron R, Little S, Perrone R, Wilt R, de Hemptinne C, Yaroshinsky MS, Racine CA, Wang SS, Ostrem JL, Larson PS, Wang DD, Galifianakis NB, Bledsoe IO, San Luciano M, Dawes HE, Worrell GA, Kremen V, Borton DA, Denison T, Starr PA. Long-term wireless streaming of neural recordings for circuit discovery and adaptive stimulation in individuals with Parkinson's disease. Nat Biotechnol. 2021 Sep;39(9):1078-1085. doi: 10.1038/s41587-021-00897-5. Epub 2021 May 3.

    PubMed 33941932
  • Torrecillos F, Tinkhauser G, Fischer P, Green AL, Aziz TZ, Foltynie T, Limousin P, Zrinzo L, Ashkan K, Brown P, Tan H. Modulation of Beta Bursts in the Subthalamic Nucleus Predicts Motor Performance. J Neurosci. 2018 Oct 10;38(41):8905-8917. doi: 10.1523/JNEUROSCI.1314-18.2018. Epub 2018 Sep 4.

    PubMed 30181135

Questions about this trial

What is this clinical trial studying?

A study testing Rhythmic Auditory Stimulation (RAS) in people with Parkinson Disease, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alexander Pantelyat, MD (4105023290, apantel1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05763732, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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