Transcutaneous Vibro-Acoustic Therapy in Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Hamilton Depression Scale score
研究概览
简要总结
Small exploratory pilot study to assess effects of a transcutaneous vibro-acoustic therapy device (Apollo Neuro) in people with Parkinson's disease (PD).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Hamilton Depression Scale score
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: after 90-120 days of intervention
Scored from 0-100, with higher score indicating greater fatigue.
Perceived Stress Scale score
时间窗: 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.
Spielberger State-Trait Anxiety Inventory score
时间窗: 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.
Geriatric Depression Scale score
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Prabesh Kanel
Research Investigator
University of Michigan