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临床试验/NCT01016743
NCT01016743Unknown不适用

The Influence of Low Frequency Repetitive Transcranial Stimulation (r-TMS) on Motor and Cognitive Measurements in Patients With Asymmetric Parkinson's Disease

Sheba Medical Center0 个研究点目标入组 20 人开始时间: 2009年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
主要终点
Unified Parkinson's Disease Rating Scale (UPDRS )

研究概览

简要总结

To test the effects of low frequency deep rTMS using the novel H-coil on the motor, affective and cognitive deficits in patients with asymmetric Parkinson's disease (PD) and to establish its safety in this population. The investigators anticipate that reaching deeper brain layers and larger volume of activation with the novel H-coil may induce significantly better therapeutic effects in patients with PD and will pave the way for establishing a novel and effective treatment for this disorder.

详细描述

PD patients with asymmetric disease aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank criteria, with Hoehn & Yahr stages II - IV while "off" will be recruited. Participants on antidepressants should be at least 2 months on stable therapy.

Patient will be excluded if:

  1. They have concomitant epilepsy, a history of seizure or heat convulsion or history of epilepsy in first degree relative.
  2. Are on neuroleptics.
  3. Have dementia or any unstable medical disorder.
  4. Have a history or current unstable hypertension.
  5. Have a history of head injury or neurosurgical interventions.
  6. Have a history of any metal in the head (outside the mouth).
  7. Have a known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.

Patients will be randomized into two groups: The first group of patients will receive an active unilateral stimulation over the motor cortex contralateral to the more affected body side (1Hz stimulation 110% of the MT for 15 minutes). Patients in the second group will receive a similar rTMS stimulation pattern over the motor cortex and over the prefrontal cortex (10Hz stimulation 100% of the MT, 2 seconds each train, 20 seconds between trains, for 15 minutes).

The following outcome measures will be taken prior to the treatment (screening visit), and at day 1, 10, 30 and 60 Evaluation will be while subjects both at "on" and "off".

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • PD patients with asymmetric disease aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank criteria, with Hoehn & Yahr stages II - IV while "off".
  • Participants on antidepressants should be at least 2 months on stable therapy.

排除标准

  • Patients who have concomitant epilepsy, a history of seizure or heat convulsion or history of epilepsy in first degree relative.
  • Patients on neuroleptics.
  • Patients with dementia or any unstable medical disorder.
  • History or current unstable hypertension.
  • History of head injury or neurosurgical interventions.
  • History of any metal in the head (outside the mouth).

结局指标

主要结局

Unified Parkinson's Disease Rating Scale (UPDRS )

时间窗: 1 year

次要结局

  • UPDRS(3 months)
  • CGIS,Pegboard test.Tapping test,Up&Go test,AIMS,BDI,MMSE,Word fluencyFAB(1 year)

研究者

申办方类型
Other Gov

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