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临床试验/CTRI/2025/10/096401
CTRI/2025/10/096401尚未招募3 期

Effect of Repetitive Transcranial Magnetic Stimulation on Freezing of gait in Parkinson’s patients a Randomized control trial

AIIMS Bhubaneswar1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年11月3日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
40
试验地点
1
主要终点
Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Freezing of Gait (FOG) in Parkinson patients

研究概览

简要总结

Freezing of gait (FOG) is a highly disabling motor symptom in Parkinson’s disease (PD), affecting approximately 32% of patients and contributing significantly to falls, injuries, and reduced quality of life (Giladi et al., 1992; Moore et al., 2007). Despite optimal pharmacologic and surgical treatments, such as levodopa therapy and deep brain stimulation, FOG often persists or worsens (Bloem et al., 2015; Xu et al., 2021). Repetitive transcranial magnetic stimulation (rTMS) has emerged as a promising non-invasive neuromodulation technique that may modulate motor networks involved in gait (Fregni & Pascual-Leone, 2007; Elahi et al., 2009). High-frequency rTMS targeting motor and supplementary motor areas has shown potential in improving motor function and reducing FOG severity (Chou et al., 2015; Zhu et al., 2015; Xie et al., 2020; Deng et al., 2022). However, the evidence remains limited due to small sample sizes and inconsistent protocols. This study aims to evaluate the efficacy of rTMS in managing FOG in PD through a rigorously designed clinical trial, potentially offering a novel therapeutic avenue for a symptom that currently lacks effective long-term treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All Parkinson disease patients with Freezing of gait.
  • Compliance with the 2015 MDS version of the PD diagnostic criteria
  • Hoehn-Yahr stage (H-Y stage) : stage 3 or less 4.Mini-Mental State Examination (MMSE) more than or equal to 24 points 5.PD medication stabilized for more than 2 weeks and no change in medication regimen during the study period 6.Being available to cooperate in completing the rTMS treatment and symptom assessment.

排除标准

  • Atypical parkinson’s disease
  • Patients with pregnancy, CLD, CKD, malignancy, severe hypertension, pacemaker or metallic implants, and history of seizures or structural brain lesions, advanced heart failure
  • Patients not providing consent for participation in study.

结局指标

主要结局

Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Freezing of Gait (FOG) in Parkinson patients

时间窗: Baseline, 1 month and 3months

次要结局

  • MRI correlation in FOG Parkinson Patients(Baseline)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Sanjeev Kumar Bhoi

AIIMS Bhubaneswar

研究点 (1)

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