Transcutaneous Vibro-Acoustic Therapy in Parkinson Disease
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Parkinson's Disease 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
Wearable device which sends low-frequency sound vibrations through the skin.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Michigan
Investigators
- Principal Investigator: Prabesh Kanel, PhD, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00231771