Vibrotactile Coordinated Reset: A Non-invasive Treatment for Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3
研究概览
简要总结
The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on motor ability within Parkinson's patients. vCR will be administered with a device called the VT Brain Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as levodopa and or deep brain stimulation. This study will include a dedicated sham that will aid in understanding true treatment effects from vCR.
详细描述
Current treatments for Parkinson's disease include medications, surgical measures, or a combination of both. However, long term use of medications can result intolerable side effects, especially at higher doses. If patients under go Deep Brain Stimulation (DBS) surgery, risks include risk of stroke, infection, seizure, hemorrhage or others we may not anticipate. Our investigators hope to confirm a non-invasive method of applying the stimulation by vibrotactile stimulation delivered through the fingertips will alleviate severity in motor symptoms in Parkinson's patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 45-85
- •Diagnosis of idiopathic Parkinson's disease
- •Bilateral impairment, as defined as Hoehn & Yahr Stages II-IV in the on-medication state
- •Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III motor improvement greater than or equal to 30% when on medication compared to when off medication.
- •Participants must be on stable dose of dopaminergic medication for 1 month prior to baseline visit.
- •Able to provide informed consent.
- •Appropriate social support if required during an off state.
- •Comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes.
- •Participants must speak English and can communicate with staff without the need of an interpreter.
- •If patient is on medication that affects brain function or alters EEG activity, the patient must feel comfortable going off this medication prior to EEG recordings
排除标准
- •Presence of other forms of non-idiopathic parkinsonism, including but not limited to atypical parkinsonism, medication-induced parkinsonism, and vascular parkinsonism.
- •Presence of other brain diseases (i.e. major depression, dementia, Attention Deficit/Hyperactivity Disorder (ADHD) psychosis, etc...).
- •Severe depression, severe anxiety, or severe psychosis for the purpose of excluding candidates at an elevated risk of suicidal tendencies.
- •Participation in another drug, device, biologic, or intervention trial concurrently or within the preceding 30 days.
- •Physical limitations unrelated to Parkinson's disease.
- •Speech problems or excessive drooling so severe patient cannot communicate properly to staff.
- •Presences of dopamine dysregulation syndrome.
- •On dopamine agonist(s) and exhibits compulsive behaviors.
- •Current delirium
- •Pregnancy, breastfeeding, or trying to get pregnant during the duration of the study.
- •History of epilepsy or traumatic brain injury.
- •Brain surgery (i.e. DBS implantation) or craniotomy.
- •Neurostimulator.
- •A type of hairstyle that would impede the use of a EEG cap
- •Severe sensory abnormalities of the fingertips such as vibratory urticaria.
- •Current or ongoing hallucinations, delusions.
- •The PI and study's neurologist deems the patient ineligible.
- •Patient has a functional movement disorder that prevents accurate Parkinson's disease evaluations
研究组 & 干预措施
Active Vibrotactile Coordinated Reset (vCR)
Participants in this arm will receive active vCR stimulation.
干预措施: Active Vibrotactile Coordinated Reset (vCR) (Device)
Sham Vibrotactile Coordinated Reset (vCR)
Participants in this arm will receive sham vCR stimulation.
干预措施: Sham Vibrotactile Coordinated Reset (vCR) (Device)
结局指标
主要结局
Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3
时间窗: 14months
This scale measures motor ability within Parkinson's patients. For part 3, the scales minimum values is 0 and max value is 132. Higher scores indicate more impaired motor ability, while lower scores indicate less impaired motor ability. A score of 0 indicates no motor impairment. This evaluation will be done in person at baseline, 3,6 and 7 months. The remote version will be done at 10, 13 and 14 months
次要结局
- PD Quality of Life Questionnaire-39 (PDQ-39)(14 months)
- Spontaneous electroencephalography (EEG)(7 months)
- University of Pennsylvania Smell Identification Test (UPSIT)(7 months)
- Parkinson's disease sleep scale (PDSS)(14 months)
- Levodopa equivalent daily dose (LEDD)(14 months)
- Vibration-only evoked EEG potentials(7 months)
- Sensorimotor task EEG(7 months)
- Vibratory temporal discrimination task (VTDT)(7 months)
- Speech and voice assessments(7 months)
- Kinesia One motor evaluation(14 months)
- Freezing of Gait Questionnaire(14 months)