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临床试验/CTRI/2024/07/069987
CTRI/2024/07/069987招募中不适用

Effect of rTMS on motor and nonmotor symptoms of progressive surpanuclear plasy : Randomised controlled study

dr deepika Joshi1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2024年7月11日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
86
试验地点
1
主要终点
to study efficacy in motor and nonmotor symptoms after cerebellar rTMS in progressive supranuclear palsy compared to sham procedure

研究概览

简要总结

this is a randomized placebo controlled trial to assess the efficacy of repetitive transcranial magnetic stimuli in motor and non motor symptoms of progressive supranuclear palsy. this trial is conducted to assess various parameters and improvement in gait after the intervention.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Double

入排标准

年龄范围
40.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • probable or possible PSP defined by MDS criteria ability to stand unassisted for 30 seconds and ability to walk independently with walker MMSE 18 or more on stable treatment of anticholinergic, dopaminergic , serotonergic sedative or NMDA receptor antagonist.

排除标准

  • history of cerebellar ataxia, subdural hematoma, space occupying lesion, hydrocephalus prior vestibular disease sensory deficit in feet epilepsy and psychotic disorder active intake of antiseizure medication pregnancy presence of electrically, magnetically active implants or metal exposures that preclude use of rTMS.

结局指标

主要结局

to study efficacy in motor and nonmotor symptoms after cerebellar rTMS in progressive supranuclear palsy compared to sham procedure

时间窗: patient will be assessed at the time of enrollment, at 1 month and at 6 months

with parameters like

时间窗: patient will be assessed at the time of enrollment, at 1 month and at 6 months

PSP rating scale

时间窗: patient will be assessed at the time of enrollment, at 1 month and at 6 months

MDS non motor rating scale

时间窗: patient will be assessed at the time of enrollment, at 1 month and at 6 months

UPDRS part III

时间窗: patient will be assessed at the time of enrollment, at 1 month and at 6 months

PSP CDS

时间窗: patient will be assessed at the time of enrollment, at 1 month and at 6 months

MOCA

时间窗: patient will be assessed at the time of enrollment, at 1 month and at 6 months

FAB

时间窗: patient will be assessed at the time of enrollment, at 1 month and at 6 months

次要结局

  • to look for non motor and behavioral changes in patients with PSP(patient will be assessed at the time of enrollment, at 1 month and at 6 months)

研究者

发起方
dr deepika Joshi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Deepika Joshi

IMS, BHU, varanasi

研究点 (1)

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