Transcutaneous Vibro-Acoustic Therapy in Parkinson Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Transcutaneous Vibro-Acoustic Therapy in Parkinson Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Transcutaneous vibro-acoustic device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parkinson's Disease<br>Participants will use the vibro-acoustic device 90-120 days for 6 hours at night on the Apollo Neuro setting Sleep and Renew. | Device: Transcutaneous vibro-acoustic device<br>* Wearable device which sends low-frequency sound vibrations through the skin.<br>* Other names: Apollo Neuro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Nighttime Heart Rate Variability | Average heart rate variability during the night, as measured by Oura ring device (measured in s). | after 90-120 days of intervention | 
| Paced Auditory Serial Addition Test score | A measure of cognitive function that assesses auditory information processing speed and flexibility, scored as the total number correct out of 60. Higher scores indicate better performance. | after 90-120 days of intervention | 
| Spielberger State-Trait Anxiety Inventory score | 40-item questionnaire to assess anxiety. Scores range from 40-160 with higher scores indicating greater severity of anxiety. | after 90-120 days of intervention | 
| Hamilton Anxiety Scale score | 14-item questionnaire to evaluate severity of anxiety symptoms. Scores range from 0-56, with higher scores indicating greater severity of anxiety. | after 90-120 days of intervention | 
| Hamilton Depression Scale score | 17-item questionnaire to assess the severity of depression symptoms. Scores range from 0-61, with higher scores indicating more severe depression. | after 90-120 days of intervention | 
| Beck Depression Inventory score | 21-item scale to evaluate the severity of depression symptoms. Scores range from 0-63, with higher scores indicating more severe depression. | after 90-120 days of intervention | 
| Beck Anxiety Inventory score | 21-item questionnaire to assess the severity of anxiety. Scores range from 0-63, with higher scores indicating greater anxiety. | after 90-120 days of intervention | 
| Geriatric Depression Scale score | 15-item questionnaire scored from 0-15, with greater scores indicating greater severity of depression. | after 90-120 days of intervention | 
| Short Activities-specific Balance Confidence Scale score | 16-item scale to assess confidence in balance while performing different tasks. Scores range from 0-100 with greater scores indicating greater confidence. | after 90-120 days of intervention | 
| New Freezing of Gait Questionnaire score | 9-item questionnaire evaluating the severity of freezing of gait. Scores range from 0-29, with higher scores indicating more severe freezing of gait. | after 90-120 days of intervention | 
| Instrumental Activities of Daily Living Scale score | 8-item questionnaire to assess functional independence. Scores range from 0-8, with higher scores indicating higher functioning. | after 90-120 days of intervention | 
| Insomnia Severity Index score | 7-item scale to assess severity of insomnia. Scores range from 0-28, with higher scores indicating greater severity of insomnia. | after 90-120 days of intervention | 
| Epworth Sleepiness Scale score | 8-item scale to assess daytime sleepiness. Scores range from 0-24, with higher scores indicating greater daytime sleepiness. | after 90-120 days of intervention | 
| Fatigue severity Scale score | 9-item scale to measure the severity of fatigue. Scores range from 9-63, with higher scores indicating greater severity of fatigue. | after 90-120 days of intervention | 
| Perceived Stress Scale score | 10-item questionnaire to evaluate perceived levels of stress. Scores range from 0-40, with greater scores indicating greater perceived stress. | after 90-120 days of intervention | 
| Short Fall Efficacy Scale International score | 7-item questionnaire to evaluate fear of falling. Scores range from 7-28 with greater scores indicating greater fear of falling. | after 90-120 days of intervention | 
| Fatigue Visual Analogue Scale score (Alternate form) | Scored from 0-100, with higher score indicating greater fatigue. | after 90-120 days of intervention | 
| Mayo Sleep Questionnaire Score on item 8 | Item 8 on the Mayo Sleep Questionnaire asks the participant to rate their general level of alertness over the past 3 weeks on a scale from 0 to 10, with 0 indicating they sleep all day and 10 indicating they are fully and normally awake. | after 90-120 days of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcutaneous vibro-acoustic therapy, anxiety