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临床试验/NCT03342846
NCT03342846已完成不适用

The Effect of High Versus Low Frequency Repetitive Transcranial Magnetic Stimulation on Motor Dysfunction in Parkinson's Disease; Which is More Beneficial?

Assiut University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年8月20日最近更新:
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
40
试验地点
1
主要终点
change in motor disability

研究概览

简要总结

The aim of the study is to compare high versus low frequency rTMS on motor dysfunction in PD. Forty patients with PD participated in the study.

The patients were randomly assigned into two groups; the first group received 1Hz and the 2nd one received 20 Hz rTMS daily for 10 days 5 sessions every week. The doctors who assess the patients clinically is blind for the frequency of rTMS, also patients don't know which type of stimulation they received. The patients were followed up before and after the 10 sessions and one month later.

详细描述

The aim of the study is to compare high versus low frequency rTMS on motor dysfunction in PD. Forty patients with PD participated in the study.

The patients were randomly assigned into two groups; the first group received 1Hz and the 2nd one received 20 Hz rTMS daily for 10 days 5 sessions every week and 2 days off per week. The doctors who assess the patients clinically is blind for the frequency of rTMS, also patients don't know which type of stimulation they received. The patients were followed up before and after the 10 sessions and one month later.

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
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All PD patients who were diagnosed according to UK bank criteria for PD.

排除标准

  • •History of repeated head injury.
  • •History of repeated cerebrovascular strokes
  • •History of defined encephalitis
  • •Oculogyric crisis, supra nuclear gaze palsy.
  • •Family history of more than one relative
  • •severe dementia, MMSE < 23, severe depression
  • •Cerebellar signs
  • •Babiniski sign
  • •Hydrocephalus or intracranial lesion on neuroimaging
  • •Patients with intracranial on neuroimaging
  • •Patients with intracranial metallic device or pacemaker
  • •Patients who were unable to give informed consent because of severe anesthesia, or cognitive deficit

研究组 & 干预措施

High Frequency rTMS in PD

Active Comparator

The first group received 20 Hz rTMS on M1 daily for 10 days 5 sessions every week.

干预措施: rTMS (Device)

Low Frequency rTMS in PD

Active Comparator

The second group received 1 Hz rTMS on M1 daily for 10 days 5 sessions every week.

干预措施: rTMS (Device)

结局指标

主要结局

change in motor disability

时间窗: one month

Measure the change in motor disability by using UPDRS and self assessment scale

次要结局

  • Changes in Cortical excitability(Two weeks)

研究者

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

Eman M. Khedr

Professor

Assiut University

研究点 (1)

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