Clinical trial NCT05962476: Transcutaneous Vibro-Acoustic Therapy in Parkinson Disease
Official title: Transcutaneous Vibro-Acoustic Therapy in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: transcutaneous vibro-acoustic therapy
anxiety
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 1
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Average Nighttime Heart Rate Variability
timeFrame: after 90-120 days of intervention
measure: Paced Auditory Serial Addition Test score
timeFrame: after 90-120 days of intervention
measure: Spielberger State-Trait Anxiety Inventory score
timeFrame: after 90-120 days of intervention
measure: Hamilton Anxiety Scale score
timeFrame: after 90-120 days of intervention
measure: Hamilton Depression Scale score
timeFrame: after 90-120 days of intervention
measure: Beck Depression Inventory score
timeFrame: after 90-120 days of intervention
measure: Beck Anxiety Inventory score
timeFrame: after 90-120 days of intervention
measure: Geriatric Depression Scale score
timeFrame: after 90-120 days of intervention
measure: Short Activities-specific Balance Confidence Scale score
timeFrame: after 90-120 days of intervention
measure: New Freezing of Gait Questionnaire score
timeFrame: after 90-120 days of intervention
measure: Instrumental Activities of Daily Living Scale score
timeFrame: after 90-120 days of intervention
measure: Insomnia Severity Index score
timeFrame: after 90-120 days of intervention
measure: Epworth Sleepiness Scale score
timeFrame: after 90-120 days of intervention
measure: Fatigue severity Scale score
timeFrame: after 90-120 days of intervention
measure: Perceived Stress Scale score
timeFrame: after 90-120 days of intervention
measure: Short Fall Efficacy Scale International score
timeFrame: after 90-120 days of intervention
measure: Fatigue Visual Analogue Scale score (Alternate form)
timeFrame: after 90-120 days of intervention
measure: Mayo Sleep Questionnaire Score on item 8
timeFrame: after 90-120 days of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Domino's Farms
state: Michigan
Study officials:
affiliation: University of Michigan
name: Prabesh Kanel, PhD
role: PRINCIPAL_INVESTIGATOR
References: