Transcutaneous Vibro-Acoustic Therapy in Parkinson Disease

University of Michigan

Status: Active, not recruiting

Conditions: Parkinson Disease

Treatments: Device: Transcutaneous vibro-acoustic device

Study type: Interventional

Funder types: Other

Identifiers

NCT05962476

HUM00231771

Details and patient eligibility

About

Small exploratory pilot study to assess effects of a transcutaneous vibro-acoustic therapy device (Apollo Neuro) in people with Parkinson's disease (PD).

Full 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 vibro-acoustic therapy device. Positive findings in this small exploratory pilot trial may support future studies of transcutaneous vibro-acoustic therapy for individuals with PD.

Enrollment: 1 patient

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Parkinson's Disease

Experimental group

Description:

Participants will use the vibro-acoustic device 90-120 days for 6 hours at night on the Apollo Neuro setting "Sleep and Renew".

Treatment:

Device: Transcutaneous vibro-acoustic device