Repetitive Transcranial Magnetic Stimulation in the Treatment of Primary Progressive Aphasia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Boston naming test evaluation
研究概览
简要总结
Primary Progressive Aphasia (PPA) is a neurodegenerative disease in which language function is gradually and progressively impaired. Patients will eventually be disabled in communication and have cognition deficits, which put a heavy burden not only on their families but also on the whole society. However, no effective treatment for PPA has been explored so far. The current clinical randomized trial is to study the safety and efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) for the treatment of PPA. Also, multi-modality of neuroimaging techniques, such as functional MRI and PET will be used to investigate brain network changing in this 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
- 是
入选标准
- •Clinical diagnosis of PPA
排除标准
- •Scored below 15 on the mini-mental state exam (MMSE)
- •history of seizures or unexplained loss of consciousness
- •pregnancy
- •surgical breach of the skull
- •MRI contraindication
研究组 & 干预措施
rTMS treatment group
The participants will be divided into the rTMS treatment group and the sham treatment group by means of randomized methods.The protocol of the treatment is to use rTMS with high frequency 10/20Hz 120%RMT 20 times for one month. The device is Magtism rTMS made in London, UK
干预措施: Magstim rTMS (Device)
sham treatment group
The control group is to receive sham treatment. The device is the same as the one used in the real treatment group.
干预措施: Magstim rTMS (Device)
结局指标
主要结局
Boston naming test evaluation
时间窗: 1 month, 3 months and 6 months after the treatment
Assessment of the language production. Scores range from 0 to 30. Higher scores means better outcome.
Western Aphasia Battery (WAB) Repetition
时间窗: 1 month, 3 months and 6 months after the treatment
Assessment of the repetition ability. Scores range from 0 to 100. Higher scores means better outcome.
Western Aphasia Battery (WAB) Word recognition
时间窗: 1 month, 3 months and 6 months after the treatment
Assessment of the reading. Scores range from 0 to 60. Higher scores means better outcome.
Western Aphasia Battery (WAB) Speech fluency
时间窗: 1 month, 3 months and 6 months after the treatment
Assessment of the language production. Scores range from 0 to 20. Higher scores means better outcome.
Syntax comprehension part of Bilingual aphasia test (Standard Modern Chinese Version)
时间窗: 1 month, 3 months and 6 months after the treatment
Assessment of the grammar ability. Scores range from 0 to 50. Higher scores means better outcome.
Boston naming test evaluation
时间窗: 1 day before the treatment
Assessment of the language production. Scores range from 0 to 30. Higher scores means better outcome.
Western Aphasia Battery (WAB) Speech fluency
时间窗: 1 day before the treatment
Assessment of the language production. Scores range from 0 to 20. Higher scores means better outcome.
Western Aphasia Battery (WAB) Repetition
时间窗: 1 day before the treatment
Assessment of the repetition ability. Scores range from 0 to 100. Higher scores means better outcome.
Western Aphasia Battery (WAB) Word recognition
时间窗: 1 day before the treatment
Assessment of the reading. Scores range from 0 to 60. Higher scores means better outcome.
Syntax comprehension part of Bilingual aphasia test (Standard Modern Chinese Version)
时间窗: 1 day before the treatment
Assessment of the grammar ability. Scores range from 0 to 50. Higher scores means better outcome.
次要结局
- functional connectivity map (FC map)(1 month, 3 months and 6 months after the treatment)
- Standardized Uptake Value (SUV)(1 month, 3 months and 6 months after the treatment)
- functional connectivity map (FC map)(1 day before the treatment)
- Standardized Uptake Value (SUV)(1 day before the treatment)