Transcutaneous Vibro-Acoustic Therapy in Parkinson Disease

Parkinson Disease Clinical Trial

Official title:

Transcutaneous Vibro-Acoustic Therapy in Parkinson Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05962476
• Other study ID #: HUM00231771
• Status: Recruiting
• Phase: N/A
• Start date: August 9, 2023
• Est. completion date: July 2025

Study information

• Verified date: August 2023
• Source: University of Michigan
• Contact: Jacqueline Caswell
• Phone: 734-936-0630
• Email: jcaswel[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Small exploratory pilot study to assess effects of a transcutaneous vibro-acoustic therapy device (Apollo Neuro) in people with Parkinson's disease (PD).

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 information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Transcutaneous vibro-acoustic device
Wearable device which sends low-frequency sound vibrations through the skin.

Locations

Country	Name	City	State
United States	Domino's Farms	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Fatigue Visual Analogue Scale score (Alternate form)	Scored from 0-100, with higher score indicating greater fatigue.	after 90-120 days of intervention
Primary	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