Multicenter Study of Safety and Effectiveness of Cala ONE Device for Essential Tremor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 8
- 主要终点
- Change in TETRAS Spiral Rating After Stimulation
研究概览
简要总结
This study evaluates the safety and effectiveness of the Cala ONE device to aid in the symptomatic relief of hand tremors in adult essential tremor subjects. This study is a prospective, randomized, double-blinded, sham-controlled study.
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
- Double (Participant, Outcomes Assessor)
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
- •22 years or older
- •A diagnosis of essential tremor as confirmed from clinical history and examination by a movement disorder neurologist
- •Signed informed consent
- •At least one hand exhibiting kinetic tremor ≥ 2 as assessed by the TETRAS Archimedes spiral task completed during the baseline evaluation, as assessed by the Investigator in-person.
- •Score of 3 or above in any one of the items of the Bain & Findley ADL Scale
排除标准
- •Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator
- •Previous thalamotomy procedure, including Stereotactic Thalamotomy, Gamma Knife Radiosurgical Thalamotomy, and focused ultrasound, for the treatment of tremor
- •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
- •Alcoholism (score of 4 or higher on DSM-5)
- •Other possible causes of tremor, including Parkinson's disease, drug-induced, enhanced physiological tremor, dystonia
- •Other neurodegenerative disease like Parkinson-plus syndromes suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and cortical basal ganglionic degeneration
- •Changes in medication for tremor within 1 month prior to study enrollment
- •Change in antidepressant medication within 3 months prior to study enrollment
- •Botulinum Toxin injection for hand tremor within 6 months prior to study enrollment
- •Current participation in any other interventional research study
- •Previous participation in any other Cala Health interventional research study
- •Alcohol or caffeine consumption within 12 hours of study enrollment
- •Subjects already taking medications for their essential tremor will remain on their medications during the study with no changes in medication type or dosage levels.
结局指标
主要结局
Change in TETRAS Spiral Rating After Stimulation
时间窗: Immediately before and after 40 minute stimulation session
The primary effectiveness variable is the change in tremor severity immediately after the stimulation session compared to baseline (immediately prior to stimulation) as measured using the TETRAS Archimedes spiral task (assessed by 3 blinded raters). The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.
次要结局
- Self-report Improvement(Immediately before and after 40 minute stimulation session)
- Change in TETRAS Spiral Rating During Stimulation(Immediately before and 30 minutes into stimulation session)