Vibrotactile Coordinated Reset: A Non-invasive Treatment for Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Movement Disorders Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) 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 function in people with Parkinson's disease (PD). vCR will be administered with a device called the Vibrotactile (VT) Touch device. vCR can be used in conjunction with medication and is expected to delay the need to increase dopamine medication. It also provides a more flexible alternative to deep brain stimulation (DBS) in that the vCR therapy can be easily stopped or modified to better suit the patients' needs.
详细描述
This vCR study will include a crossover design, where participants are their own control and receive both active stimulation and sham, aiding in understanding true treatment effects from vCR.
Current treatments for PD include medications, surgical measures, or a combination of both. However, long term use of medications can result in intolerable side effects, especially at higher doses. Although DBS is FDA approved and an established method to manage symptoms of PD, it is an invasive and expensive procedure and may not improve all symptoms of PD. The team at Synergic Medical Technologies, Inc. developed a non-invasive method of applying vibrotactile stimulation delivered through the fingertips that has the potential of theoretically disrupting abnormal synchrony in the brain and thus alleviate severity in motor symptoms in people with PD.
The purpose of this study is to test the use of vibrotactile stimulation on 30 participants with PD and vCRs effects on motor ability using the VT Touch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia and one or more of the following: rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar, or proprioceptive conditions
- •Bilateral, moderate-stage impairment, as defined as Hoehn & Yahr Stages II-IV in the on-medication state
- •Able to walk and stand unassisted
- •Participants must be on a stable regimen of PD medication (at least 4 weeks prior to enrollment)
- •Responsive to levodopa (self-reported)
- •Willing to keep exercise and medication regimen as stable as possible for the duration of the study
- •Able to provide informed consent
- •Independently, or with social support, able to use technology and access virtual meeting if needed to troubleshoot technology
- •Participants must speak English and can communicate with staff
- •Patients live close to or in the area of where the clinic is located and are able to travel to the clinic for all screening and assessment appointments.
排除标准
- •Severe depression or suicide ideation (as assessed with Beck Depression Inventory (BDI), BDI <28, and Columbia Suicide Severity Rating scale (SSRS), C-SSRS < 4)
- •*BDI score > 28, indicating severe depression that precludes ability to adhere to protocol. Any subject with such a score will be referred to a Primary Care Physician (PCP) or physician for further evaluation and management of depression. Individuals with a BDI score of 17-28 will be excluded if any of the following conditions are met: (1) individual is suicidal, (2) is in need of depression treatment modification currently or (3) depressive symptoms likely to interfere with adherence to study protocol. Any subject with such a score will be referred to a PCP or physician for further evaluation and management of depression.
- •Presence of other neurological or musculoskeletal disorders as determined by the physician during screening.
- •Participation in another drug, device, biologic, or intervention trial concurrently or within the preceding 2-month
- •Physical limitations unrelated to Parkinson's disease
- •Recent change or addition of psychoactive medications for non-parkinsonian treatments
- •Any kind of brain surgery or neurostimulators
- •Pregnancy, breastfeeding, or lack of reliable contraception in women of childbearing age
研究组 & 干预措施
Active vibrotactile coordinated reset
Participants will receive active Vibrotactile Coordinated Reset stimulation.
干预措施: Active vibrotactile coordinated reset (Device)
Sham vibrotactile coordinated reset
Participants will receive inactive Vibrotactile Coordinated Reset stimulation.
干预措施: Sham vibrotactile coordinated reset (Device)
结局指标
主要结局
Change in Movement Disorders Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3
时间窗: baseline, 2 months, 3 months, 5 months
Difference in MDS-UPDRS Part 3 from baseline to 2 months between active and sham. Range is 0-72 (18 items with 4 being max for each item), higher being worse
次要结局
- Quality of life improvements(baseline, 2 months, 3 months, 5 months)
- Change in gait speed as measured by Ambulatory Parkinson's Disease Monitoring (APDM) Mobility Lab(baseline, 2 months, 3 months, 5 months)
- Change in freezing severity index(baseline, 2 months, 3 months, 5 months)