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临床试验/NCT03219892
NCT03219892已完成不适用

Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Freezing of Gait in Parkinson's Disease

Xuanwu Hospital, Beijing2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Changes of the New Freezing of Gait Questionnaire (NFOGQ) Score

研究概览

简要总结

This study is a double blind comparative study examining the effectiveness of the rTMS treatment on Freezing of Gait (FOG) in patients with Parkinson's disease (PD). The investigators hypothesize that treatment with rTMS on supplemental motor area will improve gait quality and decrease the frequency of FOG in PD patients.

详细描述

Freezing of gait (FOG) is a common and debilitating symptom in patients with Parkinson's disease (PD), characterized by sudden and brief episodes of inability to produce effective forward stepping. FOG is a major risk factor for falls, and greatly contributes to reduced mobility and quality of daily life. Treatment of FOG has been perceived as a very challenging task. Although various treatment approaches exist, including pharmacological and surgical options, evidence is inconclusive for many approaches and no clear treatment protocols are available until now.

Repetitive transcranial magnetic stimulation (rTMS), a noninvasive neural modulation technique, has been closely applied as a treatment for various neurologic and psychiatric disorders. A recent meta-analysis demonstrated that rTMS could improve motor symptoms for PD patients with a moderate effect size. To date, however, only few rTMS studies have focused on its efficacy on FOG in patients with parkinsonism, and most of them targeted the primary motor cortex or dorsolateral prefrontal cortex . Even though some evidence indicates the involvement of the SMA in FOG, no report has described the SMA rTMS in PD patients with FOG.

Moreover, few studies combined functional magnetic resonance imaging (fMRI) and rTMS to unravel the mechanism of its beneficial effects. To address these issues, the investigators conducted a randomized, double-blind, sham-controlled study to explore the efficiency of SMA-rTMS on FOG in PD patients.

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, Investigator)

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

  • Idiopathic PD patients.
  • Presenting with FOG.
  • The mini-mental state examination questionnaire score above 24 points.

排除标准

  • Other neurological or psychiatric disorders.
  • History of epilepsy, seizures or convulsions.
  • Metal implantation.
  • History of exposure to rTMS in the past (to minimizing risk of unblinding sham condition).

结局指标

主要结局

Changes of the New Freezing of Gait Questionnaire (NFOGQ) Score

时间窗: Pre-treatment, post-treatment 4 weeks

NFOGQ ranges from 0-24 points. It is used to quantify changes of the FOG frequency and severity. Higher scores mean a worse outcome.

次要结局

  • Cadence(Pre-treatment, post-treatment 4 weeks)
  • Turning Duration(Pre-treatment, post-treatment 4 weeks)
  • Changes of Brain Functional Connectivity.(Pre-treatment, post-treatment at 2 weeks)
  • Motor Subscale of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS Part III)(Pre-treatment, post-treatment 4 weeks)

研究者

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

Piu Chan

Director

Xuanwu Hospital, Beijing

研究点 (2)

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