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临床试验/NCT01823237
NCT01823237暂停不适用

Effect of Increasing Motor Cortex Inhibition on Task Specific Dystonia

Emory University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2013年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
入组人数
15
试验地点
1
主要终点
Efficacy of TMS on task-specific focal hand dystonia

研究概览

简要总结

Dystonia is a disease where muscles in the affected body part are abnormally active. This may result in abnormal postures. The underlying mechanisms are not known. One proposed mechanism is located in the motor area of the brain that controls the coordination of muscles, called the motor cortex. It is well known that the motor area of one hemisphere of the brain (motor cortex) controls the movement of the opposite side of the body. When people perform tasks such as picking up an object or writing there are mechanisms in motor cortex that focus the level of activity so that they can do these tasks with a high level of precision. Focusing activity in motor cortex seems to be disturbed in people with dystonia. Transcranial magnetic stimulation (TMS) is a device that allows the non-invasive stimulation of the brain. When applied to the motor cortex it can upregulate or down regulate its activity. In the present study the investigators will conduct experiments on subjects with task specific focal hand dystonia (such as writers cramp) using TMS to decrease unwanted motor activity. The investigators will assess the effects of this intervention using objective, subjective and kinematic measures. This is a pilot study and will require further research to assess the long-term effects of repetitive TMS on task-specific focal hand dystonia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •If you are treated with Botulinum toxin, the testing should be done at least 3 months after your last Botulinum toxin injections.
  • •Adult patients with task-specific dystonia strictly confined to one hand since the onset of symptoms
  • •No dystonic movements at rest
  • •Normal MRI scan of the brain as per clinical record
  • •No intake of CNS active drugs that may interfere with the study
  • •No contraindication for TMS
  • •Ability to perform the selective task
  • •No other neurological disease that may interfere with the study
  • •Ability to give informed consent

排除标准

  • •You have a history of migraines
  • •You have a diagnosed seizure disorder
  • •You take any Central Nervous System CNS active drugs, such as benzodiazepines, Lorazepam, Baclofen, SSRI's and other anti-depressants, etc. that may interfere with the response to TMS.
  • •You have any clips or implants in your head
  • •You have a pacemaker

研究组 & 干预措施

rTMS

Active Comparator

rTMS condition, rTMS will be applied at 0.1-0.5 Hz frequency at a subthreshold intensity

干预措施: Transcranial Magnetic Stimulation (Device)

rTMS sham

Placebo Comparator

Placebo condition will use a sham coil and apply a very small magnetic stimulus

干预措施: Transcranial Magnetic Stimulation (Device)

结局指标

主要结局

Efficacy of TMS on task-specific focal hand dystonia

时间窗: Up to 3 weeks (2 visits)

We will assess the effects of rTMS using objective, subjective and kinematic measures. This is a pilot study and will require further research to assess the long-term effects of repetitive TMS on task-specific focal hand dystonia.

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

Cathrin Buetefisch

Associate Professor

Emory University

研究点 (1)

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