NCT06036368已完成不适用
6-weeks, Open-label, Single-Site Study to Evaluate Safety, Tolerability and Efficacy of the Home-based Peroneal Electrical Transcutaneous NeuroModulation (Peroneal eTNM®) Treatment Via Nerve Stimulator URIS ITM in Treatment of Symptoms Related to Movement Disorders in Subjects With Parkinson's Disease (PD) and Essential Tremor (ET)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Safety and tolerability
研究概览
简要总结
This is a 6-week exploratory clinical study, designed to test whether treatment with peroneal electrical trans-cutaneous stimulation can have a beneficial effects on symptoms associated with Parkinson's diseases and essential tremor.
详细描述
This is a 6-week, open-label, single site clinical study designed to test whether treatment with peroneal electrical trans-cutaneous stimulation (eTNM) can have a beneficial effects on symptoms associated with Parkinson's diseases (PD) and essential tremor (ET). Eligible patients will be treated with eTNM at home for 6 weeks. Primary endpoint in this study is tolerability and safety, secondary and exploratory endpoints are various scale designed to capture improvements in the most bothersome symptoms of PD or ET.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years of age
- •Competent and willing to provide written, informed consent to participate in the study
- •Stable dose of any chronic medications, if applicable, for 30 days prior to study entry
- •Willing to comply with study protocol requirements
- •Subject agrees not to participate in another study from 30 days prior the screening visit until the final study visit
- •For subjects with PD:
- •Bradykinesia in "on" period based on clinical assessment Rigidity in "on" period based on clinical assessment Hand/arm exhibiting tremor (resting and/or intentional and/or postural) ≥ grade 1 as assessed by the MDS-UPDRS tremor score in "on" period
- •For subjects with ET: Visible hand/arm and/or foot/leg tremor (resting and/or intentional and/or postural) ≥ grade 1 as assessed by the TETRAS
排除标准
- •Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator
- •Suspected or diagnosed epilepsy or other seizure disorder
- •Severe degree of disability or dependence in daily activities >grade 3 as measured by modified Rankin Scale (mRS)
- •Presence of clinical signs or diagnosis of dementia
- •Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
- •Presence of clinical signs of peripheral neuropathy on lower limbs
- •Presence of chorea and/or dyskinesia
- •Clinical symptoms or diagnosis of major depressive disorder
- •Presence of any other neurodegenerative disease. These may include multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease.
- •Botulinum toxin injection within 6 months prior to study enrollment
- •Participation in another interventional clinical trial in the last 30 days, which may confound the results of this study, unless approved by the Sponsor
- •Subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control (these are methods with a failure quotient of <1% year such as hormonal implants, injectable contraceptives, oral contraceptives of combination type, intra-uterine pessaries restricted to hormone contraceptive coil, sexual abstinence or vasectomy of the partner). The pregnancy test in urine at both Visits 1 and 2 needs to be negative in women of childbearing potential.
- •Subjects unable to communicate effectively with the investigator and staff
- •Life expectancy less than 6 months
- •Subject with active malignant disease
- •Subject with alcohol (more than 100 mg ethanol per day) or drug abuse during the recruitment and during the trial course
- •Subject who, in the opinion of the physician, may interfere with optimal participation in the clinical trial or may pose a risk to the subject
- •Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol
结局指标
主要结局
Safety and tolerability
时间窗: Baseline to end of treatment at 6 weeks
Incidence of treatment emergent adverse events
次要结局
- Response of the condition on the therapy(Baseline to end of treatment at 6 weeks)
研究者
研究点 (2)
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