Effects of RAS on Gait in PD Patients With DBS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Deep Brain Stimulation (DBS) Frequency Effects on Gait in Parkinson's Disease(PD)

NCT00993291

Parkinson Disease

COMPLETED PHASE1/PHASE2

Rhythmic Auditory Stimulation Optimalization for Gait Improvement in Parkinson's Disease - BeatPark Study

NCT02438124

Parkinson's Disease

UNKNOWN NA

Low Frequency Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease

NCT03204526

Parkinson Disease Cognitive Impairment

COMPLETED NA

Effects of Deep Brain Stimulation on Motor, Mood, and Cognitive Symptoms in Parkinson's Disease

NCT00360009

Parkinson Disease

COMPLETED NA

Deep Brain Stimulation Effects on Gait and Balance in Patients With Parkinson's Disease

NCT02022735

Parkinson's Disease

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Rhythmic Auditory Stimulation (RAS)

Intervention Type 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.

Post RAS

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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