Parkinson DiseaseVESTNCT05446194
Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease
A study testing Non invasive neuromodulation device pattern 1 and Non invasive neuromodulation device pattern 2 in people with Parkinson Disease, run by University of Michigan at 1 site in United States.
Trial summary
This study investigates whether vestibular (inner ear) dysfunction is a cause for poor balance in Parkinson Disease (PD), and whether inner ear stimulation with a small device may improve balance. This study will involve clinical testing, brain imaging, and an interventional treatment device for symptoms. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Non invasive neuromodulation device pattern 1 and Non invasive neuromodulation device pattern 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2021to 24 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Parkinson disease duration of 5 years or more or Hoehn \& Yahr stage 1.5-4
Who cannot join
- History of Meniere disease or recent onset of acute vestibular dysfunction, such as otolith disorders (BBPV etc).
- Other disorders which may resemble PD, such as progressive supranuclear palsy (PSP), vascular dementia, normal pressure hydrocephalus, multiple system atrophy (MSA), corticobasal ganglionic degeneration, or toxic causes of parkinsonism. Prototypical cases have distinctive clinical profiles, like early and severe dysautonomia (MSA) or appendicular apraxia, which may differentiate them from idiopathic PD and PSP. The use of the UKPDSBRC clinical diagnostic criteria for PD will mitigate the inclusion of subjects with atypical parkinsonism.
- Evidence of a stroke or mass lesion on structural brain imaging (MRI).
- Participants in whom MRI is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant.
- Severe claustrophobia precluding MR or PET imaging.
- Subjects limited by participation in research procedures involving ionizing radiation.
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- Pregnancy (test within 48 hours of each PET session) or breastfeeding.
- Subjects with active and unstable mood or anxiety disorders
- Subjects with active ear infections or perforated eardrums
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates whether vestibular (inner ear) dysfunction is a cause for poor balance in Parkinson Disease (PD), and whether inner ear stimulation with a small device may improve balance. This study will involve clinical testing, brain imaging, and an interventional treatment device for symptoms.
Read the detailed description
Basic testing of participants began in November 2021, but using the device or sham will not begin prior to July 2022.
- Conditions
- Parkinson Disease
- Being tested
- Non invasive neuromodulation device pattern 1, Non invasive neuromodulation device pattern 2
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive neuromodulation device pattern 1Device
The study device consists of a headset, which looks like a music earphone headset, and a base station that powers the headset. The headset has metallic earpieces that fit into the ear canals. When activated, the study device will deliver a prescribed stimulation pattern for approximately 20 minutes.
Non invasive neuromodulation device pattern 2Device
The study device consists of a headset, which looks like a music earphone headset, and a base station that powers the headset. The headset has metallic earpieces that fit into the ear canals. When activated, the study device will deliver a prescribed stimulation pattern for approximately 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Treatment 1 | Experimental | Investigational treatment stimulation pattern 1 Receives: Device: Non invasive neuromodulation device pattern 1 |
| Investigational Treatment 2 | Experimental | Investigational treatment stimulation pattern 2 Receives: Device: Non invasive neuromodulation device pattern 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freezing of Gait
Freezing of Gait is measured by the New Freezing of Gate Questionnaire, the current gold standard for assessment of FoG in Parkinsons Disease. Measured on a scale of 0 - 28 points with higher numbers representing more severe freezing of gait
Measured: after a week of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start12 Oct 2021
- Primary completion24 Jul 2025
- Study completion24 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Principal investigator, Chatkaew Pongmala, University of Michigan
- Investigators
- Chatkaew Pongmala, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446194
- Sponsor's protocol ID
- HUM00192613
- Other IDs
- I01 RX003397 1-01A1, I01RX003397
- Acronym
- VEST
- Status last verified
- Feb 2026
- First submitted
- 1 Jul 2022
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Per the informed consent, which allows for opt-out of data sharing, some of the observational research data and brain images collected in this study (collectively referred to as "research data") may be shared with University of Michigan investigators, investigators from outside of the University of Michigan, or may be submitted to data repositories with permission from the participant. Representatives of the Study Device Sponsor may have access to participant data but will not share it.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease
- ClinicalTrials.gov ID
- NCT05446194
- Acronym / sponsor ID
- VEST / HUM00192613
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 24 Jul 2025 (actual)
- Study completion
- 24 Jul 2025 (actual)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates whether vestibular (inner ear) dysfunction is a cause for poor balance in Parkinson Disease (PD), and whether inner ear stimulation with a small device may improve balance. This study will involve clinical testing, brain imaging, and an interventional treatment device for symptoms.
Detailed description
Basic testing of participants began in November 2021, but using the device or sham will not begin prior to July 2022.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Treatment 1 | Experimental | Device: Non invasive neuromodulation device pattern 1Investigational treatment stimulation pattern 1 |
| Investigational Treatment 2 | Experimental | Device: Non invasive neuromodulation device pattern 2Investigational treatment stimulation pattern 2 |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Parkinson disease duration of 5 years or more or Hoehn \& Yahr stage 1.5-4
Key exclusion criteria (9 listed)
- History of Meniere disease or recent onset of acute vestibular dysfunction, such as otolith disorders (BBPV etc).
- Other disorders which may resemble PD, such as progressive supranuclear palsy (PSP), vascular dementia, normal pressure hydrocephalus, multiple system atrophy (MSA), corticobasal ganglionic degeneration, or toxic causes of parkinsonism. Prototypical cases have distinctive clinical profiles, like early and severe dysautonomia (MSA) or appendicular apraxia, which may differentiate them from idiopathic PD and PSP. The use of the UKPDSBRC clinical diagnostic criteria for PD will mitigate the inclusion of subjects with atypical parkinsonism.
- Evidence of a stroke or mass lesion on structural brain imaging (MRI).
- Participants in whom MRI is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant.
- Severe claustrophobia precluding MR or PET imaging.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non invasive neuromodulation device pattern 1The study device consists of a headset, which looks like a music earphone headset, and a base station that powers the headset. The headset has metallic earpieces that fit into the ear canals. When activated, the study device will deliver a prescribed stimulation pattern for approximately 20 minutes. | Device | Investigational Treatment 1 |
| Non invasive neuromodulation device pattern 2The study device consists of a headset, which looks like a music earphone headset, and a base station that powers the headset. The headset has metallic earpieces that fit into the ear canals. When activated, the study device will deliver a prescribed stimulation pattern for approximately 20 minutes. | Device | Investigational Treatment 2 |
Primary outcome
Freezing of Gait
Time frame: after a week of treatment
Freezing of Gait is measured by the New Freezing of Gate Questionnaire, the current gold standard for assessment of FoG in Parkinsons Disease. Measured on a scale of 0 - 28 points with higher numbers representing more severe freezing of gait
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Yes. Per the informed consent, which allows for opt-out of data sharing, some of the observational research data and brain images collected in this study (collectively referred to as "research data") may be shared with University of Michigan investigators, investigators from outside of the University of Michigan, or may be submitted to data repositories with permission from the participant. Representatives of the Study Device Sponsor may have access to participant data but will not share it.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chatkaew Pongmala, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non invasive neuromodulation device pattern 1 and Non invasive neuromodulation device pattern 2 in people with Parkinson Disease, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freezing of Gait (time frame: after a week of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.