NCT05763732

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
26mo left

Started Aug 2023

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Aug 2023Jun 2028

First Submitted

Initial submission to the registry

February 28, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

4.4 years

First QC Date

February 28, 2023

Last Update Submit

April 30, 2026

Conditions

Parkinson Disease

Keywords

Parkinson diseaseDeep brain stimulationRhythmic auditory stimulation

Outcome Measures

Primary Outcomes (8)

  • 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

    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)

    Gait velocity will be calculated with a 10-meter walk. Velocity(meter/min) = 60 / time (seconds) x 10 meter

    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)

    Gait stride length will be calculated with a 10-meter walk. Stride length (meter) = Velocity / Cadence x 2

    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

    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.

    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

    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.

    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

    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.

    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

    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.

    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

    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.

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

Secondary Outcomes (1)

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

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

Study Arms (3)

Pre RAS

NO INTERVENTION

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.

During RAS

EXPERIMENTAL

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.

Behavioral: Rhythmic Auditory Stimulation (RAS)

Post RAS

NO INTERVENTION

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

Interventions

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.

During RAS

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Inability or unwillingness to follow directions for study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

RECRUITING

Related Publications (6)

  • 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.

    PMID: 26558788BACKGROUND

  • 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.

    PMID: 32849240BACKGROUND

  • 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.

    PMID: 19673759BACKGROUND

  • 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.

    PMID: 33765395BACKGROUND

  • 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.

    PMID: 33941932BACKGROUND

  • 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.

    PMID: 30181135BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Alexander Pantelyat, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Pantelyat, MD

CONTACT

4105023290apantel1@jhmi.edu

Kyurim Kang, Ph.D.

CONTACT

kkang19@jhmi.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The participant and outcomes assessor will be masked to the participants' stimulation state (OFF or ON). However, they cannot be masked whether they will receive rhythmic auditory stimulation (RAS) or not (pre-RAS or post-RAS).
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 10, 2023

Study Start

August 1, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2028

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)