Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease (VEST)

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Non invasive neuromodulation device pattern 1; Device: Non invasive neuromodulation device pattern 2

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolaas Bohnen, MD, PhD; Phone Number: 734-998-8400; Email: nbohnen@med.umich.edu
• Study Contact Backup: Name: Diane Wisnieski, LMSW; Phone Number: 734-998-4793; Email: dmschne@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • Recruiting
      • University of Michigan
      • Contact: Taylor Brown, B.S; Phone Number: 734-936-0111; Email: browntay@med.umich.edu
      • Contact: Alexis Griggs; Phone Number: 734-998-8420; Email: gralexis@med.umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Treatment 1; Investigational treatment stimulation pattern 1	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.
Experimental: Investigational Treatment 2; Investigational treatment stimulation pattern 2	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: US Department of Veterans Affairs

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2021
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: July 1, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 12, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: HUM00192613; I01 RX003397 1-01A1 (Other Grant/Funding Number: US Department of Veterans Affairs)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes