NCT05012579已完成不适用
A Study of Safety and Efficacy of Transcutaneous Afferent Patterned Stimulation (TAPS) for Reduction of Action Tremor in Parkinson's Disease (PD)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Tremor Power
研究概览
简要总结
Demonstrate safety and efficacy of TAPS delivered by a Cala device as a treatment for action tremor in subjects with Parkinson's disease hand tremor
详细描述
40 patients with PD with at least mild postural tremor were enrolled in a four-week, prospective, single-arm, open-label study of twice daily TAPS therapy. Due to the COVID-19 pandemic, TAPS devices were shipped to patients to run the study remotely. Unsupervised motion assessments were captured at home, and at the beginning and end of the four weeks by telemedicine.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be ≥22 years of age
- •Competent and willing to provide written, informed consent to participate in the study
- •Clinically significant postural tremor as defined by:
- •Dominant hand/arm exhibiting postural tremor ≥ 2 (while in the off state) as assessed by the MDS-UPDRS postural tremor score
- •Stable dose of Parkinson's disease medications, if applicable, for 30 days prior to study entry
- •Willing to comply with study protocol requirements including:
- •Having the ability to do telemedicine or video calls for study visits
- •remaining on a stable dosage of Parkinson's medications, if applicable, during the duration of the study
- •no significant caffeine consumption within 8 hours of study visits
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
- •Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
- •Peripheral neuropathy affecting the tested upper extremity
- •Presence of any other neurodegenerative disease or dementia. These may include: multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease.
- •Botulinum toxin injection for hand tremor within 6 months prior to study enrollment
- •Are participating or have participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by the Sponsor
- •Significant caffeine consumption within 8 hours of study enrollment, which may confound the results of the study, where significant caffeine is considered more than 95 mg (equivalent to a cup of coffee).
- •Subjects unable to communicate with the investigator and staff
- •Any health condition that in the investigator's opinion should preclude participation in this study
- •Pregnancy or anticipated pregnancy during the course of the study
结局指标
主要结局
Tremor Power
时间窗: 4 weeks
Pre-specified effectiveness endpoints included improvements in (1) objective postural tremor power (primary outcome; assessed using an accelerometer on the device under standard of care medication state at home).
次要结局
- Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(4 weeks)
- Bain and Findley Activities of Daily Living (BF-ADL)(4 weeks)
- Percentage of Patients With Clinician and Patient Global Impressions of Improvement Rated < 4 (CGI-I, PGI-I)(4 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis.Lower Urinary Tract SymptomsMultiple SclerosisNCT04573673University Hospital, Lille68
已完成
不适用
Upper Limb Tremor Reduction in Essential Tremor PatientsEssential TremorNCT06343285Encora, Inc.71
已完成
不适用
Transcutaneous Electrical Nerve Stimulation Treatment of Renal ColicRenal ColicNCT03237208Adiyaman University Research Hospital100
招募中
3 期
Effectiveness and Safety of TENS Therapy for Premature EjaculationSex DisorderTENPremature EjaculationNCT06425224Boston Medical Group129
已完成
不适用
the Effect of Transcutaneous Electrical Acupoint Stimulation on the Quality of Oocyte on Poor Ovarian Response(POR)Poor Ovarian ResponseNCT03994614ShangHai Ji Ai Genetics & IVF Institute92