Parkinson Disease
Conditions
Keywords
transcutaneous vibro-acoustic therapy, anxiety
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 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. This study was terminated due to lack of resources. One participant was consented, but no data was collected.
Interventions
DEVICETranscutaneous vibro-acoustic device
Wearable device which sends low-frequency sound vibrations through the skin.
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Nighttime Heart Rate Variability | after 90-120 days of intervention | Average heart rate variability during the night, as measured by Oura ring device (measured in s). |
| Paced Auditory Serial Addition Test score | after 90-120 days of intervention | 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. |
| Spielberger State-Trait Anxiety Inventory score | after 90-120 days of intervention | 40-item questionnaire to assess anxiety. Scores range from 40-160 with higher scores indicating greater severity of anxiety. |
| Hamilton Anxiety Scale score | after 90-120 days of intervention | 14-item questionnaire to evaluate severity of anxiety symptoms. Scores range from 0-56, with higher scores indicating greater severity of anxiety. |
| Hamilton Depression Scale score | after 90-120 days of intervention | 17-item questionnaire to assess the severity of depression symptoms. Scores range from 0-61, with higher scores indicating more severe depression. |
| Beck Depression Inventory score | after 90-120 days of intervention | 21-item scale to evaluate the severity of depression symptoms. Scores range from 0-63, with higher scores indicating more severe depression. |
| Beck Anxiety Inventory score | after 90-120 days of intervention | 21-item questionnaire to assess the severity of anxiety. Scores range from 0-63, with higher scores indicating greater anxiety. |
| Geriatric Depression Scale score | after 90-120 days of intervention | 15-item questionnaire scored from 0-15, with greater scores indicating greater severity of depression. |
| Short Activities-specific Balance Confidence Scale score | after 90-120 days of intervention | 16-item scale to assess confidence in balance while performing different tasks. Scores range from 0-100 with greater scores indicating greater confidence. |
| New Freezing of Gait Questionnaire score | after 90-120 days of intervention | 9-item questionnaire evaluating the severity of freezing of gait. Scores range from 0-29, with higher scores indicating more severe freezing of gait. |
| Instrumental Activities of Daily Living Scale score | after 90-120 days of intervention | 8-item questionnaire to assess functional independence. Scores range from 0-8, with higher scores indicating higher functioning. |
| Insomnia Severity Index score | after 90-120 days of intervention | 7-item scale to assess severity of insomnia. Scores range from 0-28, with higher scores indicating greater severity of insomnia. |
| Epworth Sleepiness Scale score | after 90-120 days of intervention | 8-item scale to assess daytime sleepiness. Scores range from 0-24, with higher scores indicating greater daytime sleepiness. |
| Fatigue severity Scale score | after 90-120 days of intervention | 9-item scale to measure the severity of fatigue. Scores range from 9-63, with higher scores indicating greater severity of fatigue. |
| Perceived Stress Scale score | after 90-120 days of intervention | 10-item questionnaire to evaluate perceived levels of stress. Scores range from 0-40, with greater scores indicating greater perceived stress. |
| Short Fall Efficacy Scale International score | after 90-120 days of intervention | 7-item questionnaire to evaluate fear of falling. Scores range from 7-28 with greater scores indicating greater fear of falling. |
| Fatigue Visual Analogue Scale score (Alternate form) | after 90-120 days of intervention | Scored from 0-100, with higher score indicating greater fatigue. |
| Mayo Sleep Questionnaire Score on item 8 | after 90-120 days of intervention | 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. |
Countries
United States
Outcome results
None listed