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Rhythmic Auditory Stimulation for Parkinson's Disease

N/A

Recruiting

Led By Alexander Pantelyat, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 minute (baseline 1, dbs on), 5 minutes, 10 minutes, 20 minutes (baseline 2, dbs off), 25 minutes, and 30 minutes

Awards & highlights

No Placebo-Only Group

Summary

This trial will measure the effect of rhythmic auditory stimulation on Parkinson's patients' walking ability in both their medication on and off state.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-invasive auditory stimulation rather than medication or surgery adjustments, no direct side effects are expected from the RAS intervention itself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 minute (baseline 1, dbs on), 5 minutes, 10 minutes, 20 minutes (baseline 2, dbs off), 25 minutes, and 30 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 minute (baseline 1, dbs on), 5 minutes, 10 minutes, 20 minutes (baseline 2, dbs off), 25 minutes, and 30 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 minute (baseline 1, dbs on), 5 minutes, 10 minutes, 20 minutes (baseline 2, dbs off), 25 minutes, and 30 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

+5 more

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: During RASExperimental Treatment1 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 RASActive Control1 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 RASActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rhythmic Auditory Stimulation (RAS)

2009

N/A

~100

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