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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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Change in power spectrum density of Local Fields Potential (LFP) (micro-volts-squared per Hz)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: During RASExperimental Treatment1 Intervention
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. 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. 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. 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

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,837,487 Total Patients Enrolled
Alexander Pantelyat, MDPrincipal InvestigatorJohns Hopkins University
6 Previous Clinical Trials
166 Total Patients Enrolled

Media Library

During RAS Clinical Trial Eligibility Overview. Trial Name: NCT05763732 — N/A
Parkinson's Disease Research Study Groups: During RAS, Pre RAS, Post RAS
Parkinson's Disease Clinical Trial 2023: During RAS Highlights & Side Effects. Trial Name: NCT05763732 — N/A
During RAS 2023 Treatment Timeline for Medical Study. Trial Name: NCT05763732 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to still register for this investigation?

"Clinicaltrials.gov has documented the recruitment process for this study which began on August 1st 2023 and was last modified one day later. The trial is still open to candidates."

Answered by AI

What is the total number of participants in this clinical experiment?

"Yes, this trial is still recruiting participants. As seen on clinicaltrials.gov, the study was published on August 1st 2023 and revised most recently on August 2nd 2023 with 10 enrollees sought from one medical centre."

Answered by AI

Does this research program accommodate participants of an advanced age?

"This trial has a strict age range, with the lower cutoff set to 18 years old and an upper limit of 89."

Answered by AI

Could I be qualified to participate in this medical trial?

"This trial requires 10 Parkinson's disease patients that are between 18 and 89 years old. Eligibility is further limited by two factors: a PD diagnosis, as well as implantation of Deep Brain Stimulation (DBS) in the subthalamic nucleus via PerceptTM PC technology."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effects of RAS on Gait in PD Patients With DBS
2023. "Effects of RAS on Gait in PD Patients With DBS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05763732.
All > Dbs
~7 spots leftby Apr 2026
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