Pilot Study to Demonstrate Efficacy of JOGO for the Treatment of Tremor
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in TETRAS scores 1 month
研究概览
简要总结
This research is being done to determine the effectiveness of a new treatment, called JOGO, for patients with functional tremor (FT). JOGO is a biofeedback device that has been shown to help patients with several conditions, e.g., chronic pain, migraine, and Parkinson's disease (PD)-related tremor. JOGO provides biofeedback by using wireless adhesive stickers, called surface electromyography, to get information about muscle activity. This information is then used to modify symptoms through a series of training sessions with a physical therapist and individual practice.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of functional tremor diagnosed by a Mayo Clinic Florida movement disorders specialist.
- •Must have access to reliable internet video.
排除标准
- •Cognitive impairment (Montreal Cognitive Assessment greater than 26).
- •Currently taking any of the following medications to treat tremor: primidone, gabapentin, zonisamide, any non-selective beta blocker, any benzodiazepine.
- •Exposure to tremorgenic drugs or drug with withdrawal states within 30 days prior to the study start.
- •Direct or indirect trauma to the nervous system within 3 months preceding the onset of tremor.
- •Known history of other medical or neurological conditions that may cause or explain subject's tremor, including, but not limited to: Parkinson's disease, dystonia, cerebellar disease, traumatic brain injury, alcohol abuse or withdrawal, mercury poisoning, hyperthyroidism, pheochromocytoma, head trauma or cerebrovascular disease within 3 months prior to the onset of essential tremor, multiple sclerosis, polyneuropathy, family history of Fragile X syndrome.
- •Prior MR-guided focused ultrasound or surgical intervention (e.g., deep brain stimulation, ablative thalamotomy or gamma knife thalamotomy).
- •Botulinum toxin injection in the 6 months prior to screening.
- •Use of medication(s) in the past month that might produce tremor or interfere with the evaluation of tremor, such as, but not limited to: CNS-stimulants, lithium, amiodarone, metoclopramide, theophylline, and valproate.
- •Regular use of more than two units of alcohol per day.
- •Sporadic use of a benzodiazepine, sleep medication or anxiolytic to improve sleep performance. Stable use at a consistent dose is allowed if tremor persists against the background of regular medication use.
- •Current treatment with any investigational therapy for tremor.
结局指标
主要结局
Change in TETRAS scores 1 month
时间窗: Baseline, 1-month post-treatment
Assessment with The Essential Tremor Rating Assessment Scale (TETRAS), consists of ten items in which action tremor is rated 0-4 in half-point increments by a clinician. Greater total scores indicate worse action tremor.
次要结局
- Tremor resolution 2 months(2-months post-treatment)
- Tremor resolution 1 month(1-month post-treatment)
- Change in BDI-II scores(Baseline, 1-month and 2-month post-treatment)
- Change in BAI scores(Baseline, 1-month and 2-month post-treatment)
- Change in Intolerance of Uncertainty Scale(Baseline, 1-month and 2-month post-treatment)
- Change in TETRAS scores 2 months(Baseline, 2-month post-treatment)
- Change in QUEST scores(Baseline, 1-month and 2-month post-treatment)
- Tremor prevalence(2 months)