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Behavioural Intervention

Inner Ear Stimulation for Parkinson's Disease (VEST Trial)

N/A
Recruiting
Led By Chatkaew Pongmala, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Parkinson disease duration of 5 years or more or Hoehn & Yahr stage 1.5-4
Be older than 18 years old
Must not have
Subjects with active ear infections or perforated eardrums
Subjects with active and unstable mood or anxiety disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after a week of treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial will investigate whether vestibular (inner ear) dysfunction causes poor balance in Parkinson's Disease, and whether inner ear stimulation with a device may improve balance.

Who is the study for?
This trial is for people who have had Parkinson's Disease for at least 5 years and are experiencing balance issues. They should be in the Hoehn & Yahr stages 1.5-4, which measures disease progression. Those with other conditions that mimic PD or ear problems like Meniere's disease cannot join, nor can those with brain lesions on MRI, metal implants that affect MRI safety, severe claustrophobia, exposure to too much radiation recently, pregnant or breastfeeding women, or active mood disorders.
What is being tested?
The study is testing two patterns of non-invasive neuromodulation devices designed to stimulate the inner ear to see if they can improve balance and gait in Parkinson's patients. Participants will undergo clinical tests and brain imaging alongside using these treatment devices.
What are the potential side effects?
Since this trial involves non-invasive stimulation devices rather than drugs, side effects may include discomfort at the site of application or dizziness during use. However specific side effects will depend on individual responses to device therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had Parkinson's disease for 5+ years or my condition is moderately severe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have an ear infection or a perforated eardrum.
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I have a stable mood and do not suffer from severe anxiety.
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I have a history of Meniere's disease or recent balance issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after a week of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and after a week of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Freezing of Gait

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Investigational Treatment 2Experimental Treatment1 Intervention
Investigational treatment stimulation pattern 2
Group II: Investigational Treatment 1Experimental Treatment1 Intervention
Investigational treatment stimulation pattern 1

Find a Location

Who is running the clinical trial?

US Department of Veterans AffairsFED
875 Previous Clinical Trials
498,357 Total Patients Enrolled
University of MichiganLead Sponsor
1,862 Previous Clinical Trials
6,441,053 Total Patients Enrolled
Chatkaew Pongmala, PhDPrincipal InvestigatorUniversity of Michigan
3 Previous Clinical Trials
35 Total Patients Enrolled

Media Library

Non-invasive neuromodulation device (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05446194 — N/A
Parkinson's Disease Research Study Groups: Investigational Treatment 1, Investigational Treatment 2
Parkinson's Disease Clinical Trial 2023: Non-invasive neuromodulation device Highlights & Side Effects. Trial Name: NCT05446194 — N/A
Non-invasive neuromodulation device (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05446194 — N/A
~7 spots leftby May 2025
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