Status:
TERMINATED
Transcutaneous Vibro-Acoustic Therapy in Parkinson Disease
Lead Sponsor:
University of Michigan
Conditions:
Parkinson Disease
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
Small exploratory pilot study to assess effects of a transcutaneous vibro-acoustic therapy device (Apollo Neuro) in people with Parkinson's disease (PD).
Detailed Description
The overarching goal of this study is to investigate changes in anxiety, nighttime heart rate variability, and fear of falling in people with PD before and after 3-months usage of a transcutaneous vib...
Eligibility Criteria
Inclusion
- Diagnosed with Parkinson's Disease (Hoehn and Yahr stage 2 or higher)
- Individuals on or off dopaminergic therapy
- Present of anxiety or panic disorder
- Fear of falling
- Understanding of use and care of smart phones and devices
Exclusion
- Presence of significant dementia
- Disorders which may resemble PD, such as dementia with Lewy bodies, vascular dementia, normal pressure hydrocephalus, multiple system atrophy, corticobasal ganglionic degeneration, or toxic causes of parkinsonism.
- Patients with a cardiac pacemaker
- History of brain surgery or placement of a deep brain stimulator
- Psoriasis vulgaris (or other inflammatory skin condition) on or near skin where the vibro-acoustic device and sleep tracking ring will be donned.
- Patients on beta-blockers, benzodiazepines, antipsychotics, and stimulants (except for the treatment of attention deficit disorder/ADHD).
- Pregnancy
- Patients who begin cognitive behavioral therapy or a selective serotonin reuptake inhibitor (SSRI) medication for an anxiety disorder or other psychiatric disorder after the baseline clinical assessment.
Key Trial Info
Start Date :
August 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2023
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT05962476
Start Date
August 9 2023
End Date
August 9 2023
Last Update
August 1 2025
Active Locations (1)
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1
Domino's Farms
Ann Arbor, Michigan, United States, 48105