Transcutaneous Vibro-Acoustic Therapy in Parkinson Disease
- Conditions
- Parkinson Disease
- Interventions
- Device: Transcutaneous vibro-acoustic device
- Registration Number
- NCT05962476
- Lead Sponsor
- University of Michigan
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Parkinson's Disease Transcutaneous vibro-acoustic device Participants will use the vibro-acoustic device 90-120 days for 6 hours at night on the Apollo Neuro setting "Sleep and Renew".
- Primary Outcome Measures
Name Time Method 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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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 Visual Analogue Scale score (Alternate form) after 90-120 days of intervention Scored from 0-100, with higher score indicating greater fatigue.
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.
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.
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.
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Domino's Farms
🇺🇸Ann Arbor, Michigan, United States