NCT00863226Unknown3 期
A Randomized, Double-Blind, Sham-Stimulation Controlled Study of the Application of Magnetic Fields Using the Resonator Device for the Treatment of Parkinson's Disease: Phase Three Clinical Trial Protocol
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 72
- 试验地点
- 11
- 主要终点
- Change in PDQ-39 single index score
研究概览
简要总结
The purpose of this study is to see if a device called the Resonator can help to improve aspects of health and quality of life that are relevant to patients with Parkinson's disease.
详细描述
This clinical trial will evaluate a new non-invasive, non-significant risk, device therapy as an adjuvant symptomatic treatment for some of the signs and or symptoms of Parkinson's Disease (PD). The device utilizes patented technology involving extremely low level electromagnetic fields.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's Disease
- •Stable optimized anti-PD drugs for at least 4 weeks
- •PDQ-39 Summary Index between 15 and 45
- •Ambulatory
- •Willing to maintain regular medication regime throughout study
- •Able to abstain from starting in new treatments to improve PD symptoms during course of study.
- •No prior surgical interventions for Parkinson's Disease
- •Non-demented
- •Minimum of 30 years of age, but not older than 85
- •Capable of giving full written consent
排除标准
- •Atypical Parkinsonism such as progressive supranuclear palsy, multiple system atrophy, CBDG etc.
- •Subjects may not have any of the following: active brain tumor, strokes, hydrocephalus, any other neurologic or non-neuro problem which may affect symptomatic expression of patients parkinsonism.
- •Consumption of medications that can produce drug induced parkinsonism
- •Chronic pain not associated with PD
- •Current or past history of major psychiatric disturbance
- •No typical or non-typical anti-psychotics for treatment of drug induced psychosis.
- •Chronic fatigue
- •Epilepsy or history of epilepsy
- •Seizures or taking medication for epilepsy
- •HIV or other autoimmune disorders
- •History of ECT
- •Uncontrolled hypertension
- •Advanced pulmonary disease
- •Unstable cardiac disease
- •Prior surgical interventions for Parkinson's disease
- •Prosthetics or implants comprised of ferrous metals
- •Pacemaker, vagus nerve stimulators, or other functional electrical stimulators such as those commonly used for pain
- •Pregnant, breast feeding or planning pregnancy prior to study end
- •Dementia, developmental disability, psychiatric disorder or other cognitive impairment
- •Any significant medical condition that may require alteration of medical therapy during the study, or major medical condition which may interfere with the study activity.
结局指标
主要结局
Change in PDQ-39 single index score
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
研究点 (11)
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