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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non invasive neuromodulation device pattern 1
Non invasive neuromodulation device pattern 2
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Investigational Treatment 1

Investigational Treatment 2

Arm Description

Investigational treatment stimulation pattern 1

Investigational treatment stimulation pattern 2

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 1, 2022
Last Updated
November 8, 2022
Sponsor
University of Michigan
Collaborators
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT05446194
Brief Title
Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease
Acronym
VEST
Official Title
Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
US Department of Veterans Affairs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigational Treatment 1
Arm Type
Experimental
Arm Description
Investigational treatment stimulation pattern 1
Arm Title
Investigational Treatment 2
Arm Type
Experimental
Arm Description
Investigational treatment stimulation pattern 2
Intervention Type
Device
Intervention Name(s)
Non invasive neuromodulation device pattern 1
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Non invasive neuromodulation device pattern 2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Freezing of Gait
Description
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
Time Frame
after a week of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Parkinson disease duration of 5 years or more or Hoehn & Yahr stage 1.5-4 Exclusion Criteria: 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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolaas Bohnen, MD, PhD
Phone
734-998-8400
Email
nbohnen@med.umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Diane Wisnieski, LMSW
Phone
734-998-4793
Email
dmschne@med.umich.edu
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taylor Brown, B.S
Phone
734-936-0111
Email
browntay@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Alexis Griggs
Phone
734-998-8420
Email
gralexis@med.umich.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Vestibulopathy, Imbalance, and Gait Disturbances in Parkinson Disease

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