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临床试验/NCT07731841
NCT07731841已完成不适用

Mechanisms of Differential Response to Transcranial Magnetic Stimulation in Freezing of Gait in Parkinson's Disease and Cerebellar Stimulation Intervention for Treatment-Resistant Patients

The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2021年9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
85
试验地点
1
主要终点
Freezing of Gait Questionnaire Improvement Rate

研究概览

简要总结

This study evaluated transcranial magnetic stimulation (TMS) for freezing of gait in patients with Parkinson's disease. Participants with Parkinson's disease and freezing of gait received conventional TMS protocols, and their clinical, gait, and neurophysiological outcomes were assessed. Patients who did not achieve sufficient improvement after conventional TMS were further treated with a combined primary motor cortex and cerebellar stimulation protocol. The study aimed to identify factors associated with differential response to conventional TMS and to explore whether cerebellar stimulation could improve symptoms in treatment-resistant patients.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • (1) a score of ≥ 1 on MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Item 13 or FOGQ Item 3, with freezing episodes during gait initiation, turning, or navigating narrow spaces confirmed by two independent investigators; (2) a stable antiparkinsonian medication regimen for at least four weeks before enrollment; (3) right-handedness; (4) age ≥ 40 years; (5) no current use of antidepressants, anxiolytics, or antipsychotic agents. Antiparkinsonian medications and their dosages remained unchanged throughout the study.

排除标准

  • (1) personal or family history of atypical parkinsonian syndromes, including multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, Wilson's disease, and vascular parkinsonism; (2) coexisting movement disorders or other neurodegenerative conditions; (3) gait-impairing disorders such as primary progressive freezing of gait; (4) impaired consciousness, or visual, auditory, or language deficits that precluded full assessment; (5) severe systemic diseases, including cardiopulmonary disorders, hepatic or renal insufficiency, malignancies, and hematologic or autoimmune diseases; (6) prior cranial surgery or deep brain stimulation (DBS); (7) pregnancy; (8) history of epilepsy; (9) severe cognitive impairment with a Mini-Mental State Examination (MMSE) score below 24; and (10) other contraindications to TMS.

结局指标

主要结局

Freezing of Gait Questionnaire Improvement Rate

时间窗: Baseline and 1 month after treatment

The improvement rate of the Freezing of Gait Questionnaire was calculated as \[(pre-treatment FOGQ score at baseline - post-treatment FOGQ score at one-month follow-up) / pre-treatment FOGQ score at baseline\] × 100%. Participants with an improvement rate of at least 30% were classified as treatment responsive.

次要结局

  • Unified Parkinson's Disease Rating Scale Part III Score(Baseline, within 24 hours after treatment, and 1 month after treatment)
  • Upper-Limb Short-Interval Intracortical Inhibition(Baseline and within 24 hours after treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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