Rhythmic Auditory Stimulation for Parkinson's Disease

Overseen By Kyurim Kang, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Inability, Unwillingness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Is Rhythmic Auditory Stimulation (RAS) safe for humans?

The research on Rhythmic Auditory Stimulation (RAS) for Parkinson's disease does not report any safety concerns, suggesting it is generally safe for humans. ^{1 2 3 4 5}

How is rhythmic auditory stimulation different from other treatments for Parkinson's disease?

Rhythmic auditory stimulation (RAS) is unique because it uses sound cues, like metronomes or music, to help improve walking patterns in people with Parkinson's disease. Unlike traditional medications, RAS focuses on enhancing movement through auditory signals, which can help with gait disturbances by improving timing and coordination. ^{1 2 3 4 6}

What data supports the effectiveness of the treatment Rhythmic Auditory Stimulation (RAS) for Parkinson's Disease?

Research shows that Rhythmic Auditory Stimulation (RAS) can help improve walking patterns in people with Parkinson's disease by increasing walking speed, step length, and balance. Studies have found that using sounds like metronomes or music can help people with Parkinson's walk more steadily and confidently. ^{1 2 3 4 6}

Who Is on the Research Team?

Alexander Pantelyat, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for Parkinson's Disease patients who have had a Deep Brain Stimulation (DBS) device implanted. Participants should be able to follow study directions and must already be using the PerceptTM PC with their DBS.

Inclusion Criteria

I have been diagnosed with Parkinson's disease.

I have Parkinson's and a PerceptTM PC device implanted for Deep Brain Stimulation.

Exclusion Criteria

Inability or unwillingness to follow directions for study procedures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-RAS Assessment

Participants undergo assessments to measure gait parameters and patterns during stimulation ON and OFF using the 10-meter walk and MDS-UPDRS-III rating scale.

10 minutes

1 visit (in-person)

RAS Treatment

Participants walk to the metronome beats for four minutes, and gait parameters are recorded. Electrophysiological activity is collected.

4 minutes

1 visit (in-person)

Post-RAS Assessment

The same assessment as the Pre-RAS is conducted to measure changes in gait parameters and patterns.

10 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rhythmic Auditory Stimulation (RAS)

Trial Overview The study tests if walking to metronome beats, known as Rhythmic Auditory Stimulation (RAS), affects how people with Parkinson's walk. It measures changes in walking speed, step length, and rhythm before, during, and after RAS when their DBS is on or off.

How Is the Trial Designed?

Group I: During RAS Experimental Treatment 1 Intervention

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 II: Pre RAS Active Control 1 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.

Group III: Post RAS Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

In a study involving 31 patients with Parkinson's disease and 10 healthy elderly subjects, rhythmic auditory stimulation (RAS) significantly improved gait velocity, cadence, and stride length, especially when the rhythm was set 10% faster than the participants' baseline cadence.

The findings suggest that RAS can effectively facilitate gait rehabilitation in individuals with Parkinson's disease, even in the presence of basal ganglia dysfunction, highlighting the potential for using rhythmic auditory cues in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rhythmic auditory-motor facilitation of gait patterns in patients with Parkinson's disease. McIntosh, GC., Brown, SH., Rice, RR., et al.[2022]

A study involving 38 individuals with Parkinson's disease showed that both ecological and artificial rhythmic auditory stimulation (RAS) integrated into rehabilitation programs improved gait and clinical measures after 5 weeks of treatment.

Notably, improvements in spatio-temporal gait parameters were specifically observed in the ecological RAS group, suggesting potential benefits of using natural sounds in rehabilitation for Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Footstep Sounds as Rhythmic Auditory Stimulation for Gait Rehabilitation in Parkinson's Disease: A Randomized Controlled Trial. Murgia, M., Pili, R., Corona, F., et al.[2022]

Rhythmic auditory stimulation (RAS) using music was found to be more effective than metronomes for helping participants maintain motor timing during tasks, particularly at medium and fast tempos, suggesting that music can enhance movement coordination.

Stepping on the spot resulted in better entrainment and more stable pacing compared to finger and toe tapping, indicating that this type of movement may be particularly beneficial for individuals with Parkinson's disease in managing their gait and motor control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music and Metronomes Differentially Impact Motor Timing in People with and without Parkinson's Disease: Effects of Slow, Medium, and Fast Tempi on Entrainment and Synchronization Performances in Finger Tapping, Toe Tapping, and Stepping on the Spot Tasks. Rose, D., Delevoye-Turrell, Y., Ott, L., et al.[2022]

In a 3-week home-based gait-training program for 15 Parkinson's disease patients, rhythmic auditory stimulation (RAS) significantly improved gait velocity by 25%, stride length by 12%, and step cadence by 10% compared to control groups.

The RAS group also showed notable changes in muscle activation patterns and was able to maintain improved walking speed within a 2% margin of error after training, indicating effective rhythmic entrainment of their gait patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rhythmic auditory stimulation in gait training for Parkinson's disease patients. Thaut, MH., McIntosh, GC., Rice, RR., et al.[2022]

Rhythmic auditory stimulation (RAS) significantly improves gait parameters in Parkinson's disease patients, including increased stride length and gait speed, as well as reduced freezing events during walking, based on a meta-analysis of 18 studies involving 774 subjects.

RAS also enhances overall motor functions and quality of life, as indicated by improvements in the Unified Parkinson's Disease Rating Scale (UPDRS) scores and the Parkinson's Disease Quality of Life Questionnaire (PDQL) over a treatment period of 1-26 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rhythmic auditory stimulation promotes gait recovery in Parkinson's patients: A systematic review and meta-analysis. Ye, X., Li, L., He, R., et al.[2022]

Rhythmic auditory stimulation (RAS) significantly improved upper-limb movement performance in patients with Parkinson's disease (PD) during tasks, indicating its potential as a therapeutic tool for alleviating bradykinesia.

The study involved 23 PD patients and 23 healthy controls, showing that faster RAS tempos (120% of baseline) led to better performance across all tasks, suggesting that RAS can effectively enhance motor function through its influence on auditory and motor brain connections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of rhythmic auditory stimulation on upper-limb movements in patients with Parkinson's disease. Fan, W., Li, J., Wei, W., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Rhythmic auditory-motor facilitation of gait patterns in patients with Parkinson's disease. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Use of Footstep Sounds as Rhythmic Auditory Stimulation for Gait Rehabilitation in Parkinson's Disease: A Randomized Controlled Trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Music and Metronomes Differentially Impact Motor Timing in People with and without Parkinson's Disease: Effects of Slow, Medium, and Fast Tempi on Entrainment and Synchronization Performances in Finger Tapping, Toe Tapping, and Stepping on the Spot Tasks. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Rhythmic auditory stimulation in gait training for Parkinson's disease patients. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Rhythmic auditory stimulation promotes gait recovery in Parkinson's patients: A systematic review and meta-analysis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Effects of rhythmic auditory stimulation on upper-limb movements in patients with Parkinson's disease. [2022]