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临床试验/NCT03720691
NCT03720691尚未招募不适用

Effect of Repetitive Transcranial Magnetic Stimulation in Vascular Parkinsonism

Inje University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2018年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
32
试验地点
1
主要终点
Unified Parkinson's Disease Rating Scale (UPDRS) part III-motor part (Number 18 ~31 of UPDRS)

研究概览

简要总结

Vascular parkinsonism (VP), parkinsonism resulting from ischemic cerebrovascular disease, was suggested in 1929. The main features are wide-based gait, postural instability, and falls, which make patients with VP frustrated. Currently, the treatment is challenging.

Transcranial magnetic stiumation is a noninvasive procedure using electromagnetic induction to stimulate brain, and repetitive transcranial magnetic stiumation (rTMS) can selectively change brain activity to enhance desired effects. The aim of this study is to explore the therapeutic effect of rTMS for the VP.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Vascular parkinsonism
  • age 18 and older

排除标准

  • pregnant or any, other medical, surgical, neurological or psychiatric conditions
  • other restrictions which prevent you from undergoing TMS recording, such as; surgically or traumatically implanted foreign bodies such as a pacemaker, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings), and/ or heart/cardiac lines
  • any past or current history of seizure disorder or epilepsy
  • unable to give informed consent

研究组 & 干预措施

Real rTMS Supplementary motor area

Active Comparator

Real rTMS will be applied over the supplementary motor area

干预措施: Real rTMS Supplementary motor area (Device)

Sham rTMS Supplementary motor area

Sham Comparator

Sham rTMS will be applied over the supplementary motor area

干预措施: Sham rTMS Supplementary motor area (Device)

结局指标

主要结局

Unified Parkinson's Disease Rating Scale (UPDRS) part III-motor part (Number 18 ~31 of UPDRS)

时间窗: 2 days

Motor functions will be checked using UPDRS. Each item of the motor part ranges from 0 to 4 (0 means normal, 4 means worst condition). Total sum will be calculated.

次要结局

  • The total number of steps during the stand-walk-sit (SWS) test(2 days)
  • Freezing episodes of gait trajectory(2 days)
  • Finger tapping test with right hand(2 days)
  • The completion time during the SWS test(2 days)
  • Patient and Clinical Global Impression Scale(2 days)

研究者

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

Sangjin Kim

Professor

Inje University

研究点 (1)

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