NCT06559098尚未招募不适用
Vibrotactile Coordinated Reset for the Treatment of Advanced Parkinson's Disease Patients Who Have Previously Received vCR Stimulation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5
- 主要终点
- Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) off medication
研究概览
简要总结
The purpose of this study is to test the efficacy of vibrotactile coordinated reset stimulation on human subject participants with advanced stage Parkinson's Disease who have previously received vCR therapy.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any adult age 18 and older
- •Idiopathic Parkinson's Symptoms between Hoehn and Yahr stages 2 to 4
- •Fluent in English
- •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 recording
- •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.
- •Feels comfortable going off PD related medication during in person study visits
- •Lives in the United States
- •Having previously been enrolled in a vCR pilot study
排除标准
- •Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies
- •Any current drug or alcohol abuse.
- •Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
- •Pregnancy, breast-feeding or wanting to become pregnant
- •Physical limitations unrelated to PD that would affect motor ratings
- •Craniotomy
- •Brain surgery
- •Patient is unable to communicate properly with staff (i.e., severe speech problems)
- •Excessive drooling
- •A type of hairstyle that would impede the use of an EEG cap
- •Sensory abnormalities of the fingertips
- •Patient is taking a medication that may cause significant withdrawal effects.
- •Presence or diagnosis of Essential Tremor, psychogenetic tremor, functional tremor and any other non- pathological or non-Parkinsonian tremors
结局指标
主要结局
Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) off medication
时间窗: Baseline, 3Months,6 Months, 9 Months 12 Months, 18 Months, 24 Months
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.
次要结局
- Levodopa equivalent daily dose (LEDD) daily change from baseline to 24 months(24 months)
- Parkinson's disease quality of life questionnaire-39 (PDQ-39)(24 months)
- Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 2(24 months)
- Freezing of Gait Questionnaire (FOG) change(24 months)
- Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1 change(24 months)
- Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 4 change(24 months)
- Communicative Participation Item Bank (CPIB; Short Form)(24 months)
- Voice Handicap Index (VHI-10)(24 months)
- Spontaneous Electroencephalography beta band power change(24 months)
- Parkinson's disease cognitive functional rating scale (PD-CFRS)(24 months)
- Device calibration(24 months)
研究者
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