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临床试验/NCT03448133
NCT03448133撤回不适用

Repetitive Transcranial Magnetic Stimulation for the Treatment of Primary Progressive Aphasia: A Randomized Controlled Tria

Peking Union Medical College Hospital0 个研究点开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version)

研究概览

简要总结

The primary progressive aphasia (PPA) is a neurodegenerative condition characterized by a gradual, irreversible decline of language function (Mesulam, 2001). There are no known treatments for PPA so far. The relentless progression of PPA symptoms eventually leads to a profound impairment in communication ability and, ultimately, to more generalized deficits of cognition. Some cases and small studies reported that Transcranial Magnetic Stimulation (TMS), one of the non-invasive neuromodulation tech, can be employed to facilitate language production and improve the language ability in patients with PPA. Herein we will explore the tolerance and efficacy of TMS for the treatment of PPA by the randomized controlled trial .Meanwhile the functional MRI tech will be used to investigate the neural network changing in the procedure

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
35 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All participants had also been evaluated previously by a behavioral neurologist at the Peking Union Medical College Hospital and had been clinically diagnosed with a variant of PPA.

排除标准

  • Scored below 15 on the mini-mental state exam (MMSE) due to concerns that global cognitive impairment might preclude their ability to follow the directions and interfere with task performance.
  • Had a history of seizures or unexplained loss of consciousness, pregnancy, surgical breach of the skull, or any other medical or surgical contraindication to receiving noninvasive brain stimulation.
  • Is unable to complete the treatment and evaluations

结局指标

主要结局

Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version)

时间窗: One month(just after 20 times rTMS treatment)

Assessment of the grammar ability

Boston naming test evaluation

时间窗: One month(just after 20 times rTMS treatment)

Assessment of the language production

Western Aphasia Battery(WAB) Speech fluency

时间窗: One month(just after 20 times rTMS treatment)

Assessment of the language production

Repetition Part of WAB

时间窗: One month(just after 20 times rTMS treatment)

Assessment of the repetition ability

Word recognition Part of WAB

时间窗: One month(just after 20 times rTMS treatment)

Assessment of the reading

次要结局

  • fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length)(One month(just after 20 times rTMS treatment))

研究者

申办方类型
Other
责任方
Sponsor

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