Upper Limb Tremor Reduction in Essential Tremor Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Tolerability (Rate of Subject-Assessed Comfort with Stimulation)
研究概览
简要总结
This study is designed to demonstrate the safety, tolerability, and efficacy of the Encora Therapeutics Tremor Mitigation Device in subjects with upper limb tremor caused by Essential Tremor.
详细描述
A prospective, randomized, blinded clinical trial. Subjects meeting all inclusion criteria will have five days of treatment with each of the three arms, received in a randomized order. Subjects will complete two rounds of assessments each day.
Arm 1: Inactive stim Arm 2: Stim therapy utilizing a specific dermatome Arm 3: Stim therapy utilizing a tailored frequency
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization schedule maintained by non-Clinical personnel
入排标准
- 年龄范围
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion/Exclusion:
- •Inclusion Criteria:
- •Between the ages of 22 and 80 years of age
- •A diagnosis of essential tremor (definite or probable based on TRIG criteria)
- •At least one hand exhibiting tremor > 2 as assessed by the Essential Tremor Rating
- •Assessment Scale (TETRAS) finger to nose task, duck wing task, OR Archimedes Spiral completed during the Screening visit
- •Stable tremor medications for at least 30 days prior to enrollment and the ability to maintain stable medications through the duration of the study
- •Randomization Inclusion Criteria
- •During the Baseline evaluation period, a median tremor score of > 2 on at least one hand as assessed by the TETRAS finger to nose task, the duck wing task, OR the Archimedes Spiral AND
- •During the Baseline evaluation period, a median score of > 3 on any one of the subject-assessed items of the Bain & Findley Activities of Daily Living Scale (BF-ADL)
排除标准
- •Previous surgical interventions for tremor reduction on the upper limb being used for inclusion in this study (eg, thalamotomy procedure, including Stereotactic Thalamotomy, Gamma Knife Radiosurgical Thalamotomy, or focused ultrasound)
- •Use of botulinum toxin for treatment to hand tremor within six months of enrollment
- •Suspected or diagnosed epilepsy or other seizure disorder
- •Other possible causes of tremor, including Parkinson's disease, drug-induced tremor, or dystonia
- •Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
- •Numbness, tingling or pain affecting the tested upper extremity (eg, suspected or confirmed peripheral neuropathy, carpal tunnel syndrome)
- •Known allergy to silicone
- •Subjects are unable or unwilling to comply with the protocol requirements
- •Subject is part of a vulnerable population who is unable to give Informed Consent for reasons of incapacity, dementia, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent.
- •Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.
结局指标
主要结局
Tolerability (Rate of Subject-Assessed Comfort with Stimulation)
时间窗: At the end of the 5-day treatment period in all randomization arms
The rate of subject-assessed comfort with stimulation, on a Subject Stimulation Tolerance Questionnaire as measured by % of patient who tolerated the treatment either none of the time, some of the time or all of the time.
Safety (Rate of Adverse Events)
时间窗: At the end of the 5-day treatment period in all randomization arms
The rate of occurrence of adverse events (AEs) as both total numbers of AEs experienced throughout the study and percentage of subjects who experienced an AE.
次要结局
- Tremor power as measured by gyroscope(At the end of the 5-day treatment period in all randomization arms)
- Bain & Findley Activity of Daily Living (BF-ADL) #2(At the end of the 5-day treatment period in all randomization arms)
- BF-ADL #4(At the end of the 5-day treatment period in all randomization arms)
- BF-ADL #17(At the end of the 5-day treatment period in all randomization arms)
- BF-ADL #21(At the end of the 5-day treatment period in all randomization arms)
- Patient Global Impression of Change (PGI-C)(At the end of the 5-day treatment period in all randomization arms)
- Clinician Global Impression of Change (CGI-C)(At the end of the 5-day treatment period in all randomization arms)