Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease

Parkinson Disease Clinical Trial

— VEST  

Official title:

Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05446194
• Other study ID #: HUM00192613
• Secondary ID: I01 RX003397 1-0
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: May 31, 2024

Study information

• Verified date: November 2023
• Source: University of Michigan
• Contact: Nicolaas Bohnen, MD, PhD
• Phone: 734-998-8400
• Email: nbohnen[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

Basic testing of participants began in November 2021, but using the device or sham will not begin prior to July 2022.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

1. Parkinson disease duration of 5 years or more or Hoehn & Yahr stage 1.5-4

Exclusion Criteria:

1. History of Meniere disease or recent onset of acute vestibular dysfunction, such as otolith disorders (BBPV etc).

2. 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.

3. Evidence of a stroke or mass lesion on structural brain imaging (MRI).

4. 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.

5. Severe claustrophobia precluding MR or PET imaging.

6. Subjects limited by participation in research procedures involving ionizing radiation.

7. Pregnancy (test within 48 hours of each PET session) or breastfeeding.

8. Subjects with active and unstable mood or anxiety disorders

9. Subjects with active ear infections or perforated eardrums

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Non invasive neuromodulation device pattern 1
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 2
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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	after a week of treatment