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临床试验/NCT02704793
NCT02704793已完成不适用

Assessing Clinical Effectiveness of Cerebellar Repetitive Transcranial Magnetic Stimulation (rTMS) on Severity of Motor Signs of Essential Tremor

Mashhad University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2016年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
1
主要终点
change in score of Fahn-Tolosa-Marin scale

研究概览

简要总结

Essential tremor (ET) is a low-mortality, though truly burdensome and debilitating condition which is known to be the second most common movement disorder of the adult population only after restless legs syndrome. The prevalence of the disorder in all age groups has been estimated to be 0.9%. Repetitive transcranial magnetic stimulation (rTMS) is an almost safe technique which has been used in diagnosis and treatment of many neurologic and psychiatric conditions. Recent studies have shown that cerebellum has a significant role in development of ET and that rTMS could exert therapeutic effects on its motor symptoms. In this study researchers will recruit at least 30 subjects among patients visiting at the Specialty Clinic of Mashhad Medical University according to researchers exclusion and inclusion criteria and after signing a written informed consent, will randomly be assigned to either real or sham rTMS. On the real rTMS arm, patients will be treated with 900 pulses of 1 Hz rTMS on 90% of resting motor threshold (RMT) delivered over each cerebellar hemisphere for 5 consecutive days and sham treatment will be performed with the same protocol using a small device placed on the TMS coil (not visible to the patients) producing electrical stimulation (less than 3 mili amperes), to simulate the sensation of real TMS. Subject's ear will be protected with earplugs during both real and sham stimulations. After 2 months of follow-up, patients will undergo crossover and receive the other treatment as described above. Patients would be assessed using Fahn-Tolosa-Marin scale at the baseline and again on days 5, 12, and 30 after each real or sham treatment session by a blinded researcher. Data will be analysed by another researcher who is also blind.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • having a diagnosis of essential tremor (ET) based on Movement Disorder Society criteria, involving at least one hand.
  • 18 years or above
  • cognitively eligible to give informed consent of participation in the trial.

排除标准

  • Cardiac pace-maker or other implanted magnetic device or having other contraindications of performing a routine non-contrast MRI
  • skin defect at the occipital area preventing placement of a coil
  • Currently pregnant or plan for pregnancy in the next 6 months
  • History of seizure
  • Other comorbid medical conditions capable of producing or enhancing tremor
  • advanced cardiac, renal, hepatic or other disabling conditions making patient physical unable to participate in examination and receiving the intervention
  • Use of new drugs with potential effect on tremor

研究组 & 干预措施

Bilateral 1 Hz Cerebellar rTMS

Experimental

Patients will be treated with 900 pulses of 1 Hz rTMS on 90% of resting motor threshold (RMT) delivered over each cerebellar hemisphere for 5 consecutive days.

干预措施: Bilateral 1 Hz Cerebellar rTMS (Other)

Sham (electrical stimulation)

Sham Comparator

Sham treatment will be performed with the same protocol using a small device placed on the TMS coil (not visible to the patients) producing electrical stimulation (less than 3 mili amperes), to simulate the sensation of real TMS.

干预措施: Sham (electrical stimulation) (Other)

结局指标

主要结局

change in score of Fahn-Tolosa-Marin scale

时间窗: at the baseline and on days 5, 12, and 30 after each real or sham treatment session.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nahid Olfati

Dr

Mashhad University of Medical Sciences

研究点 (1)

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