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Study discontinued due to a lack of resources.
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson's Disease | Experimental | Participants will use the vibro-acoustic device 90-120 days for 6 hours at night on the Apollo Neuro setting "Sleep and Renew". |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous vibro-acoustic device | Device | Wearable device which sends low-frequency sound vibrations through the skin. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prabesh Kanel, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Domino's Farms | Ann Arbor | Michigan | 48105 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001523 | Mental Disorders |