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Behavioural Intervention

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

N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after a week of treatment
Awards & highlights

VEST Trial 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.Check my eligibility
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.See study design
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.

VEST Trial Eligibility Criteria

Inclusion Criteria

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

VEST Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Freezing of Gait

VEST 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
867 Previous Clinical Trials
487,786 Total Patients Enrolled
University of MichiganLead Sponsor
1,787 Previous Clinical Trials
6,365,470 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

Frequently Asked Questions

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

Could you provide an estimation of the amount of participants involved in this clinical experiment?

"Affirmative. According to the data on clinicaltrials.gov, this research is currently in its recruitment phase since it was initially posted on October 12th 2021 and revised most recently on November 8th 2022. The trial needs 64 subjects from one physical site for successful completion."

Answered by AI

Is this medical trial accepting new participants?

"Affirmative, the information posted on clinicaltrials.gov shows that this investigation is recruiting participants. The research was initially made available to the public on October 12th 2021 and has since had a few updates as of November 8th 2022. 64 individuals are needed at one medical facility for the trial's intent."

Answered by AI
~4 spots leftby May 2024