Transcranial Magnetic Stimulation in Primary Progressive Aphasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes in reading
研究概览
简要总结
Primary progressive aphasia (PPA) is a clinical syndrome characterized by the neurodegeneration of language brain systems. Three main clinical variants are currently recorgnized (nonfluent, semantic, and logopenic PPA). Nowadays, there are no effective treatments for this disorder.
Transcranial Magnetic Stimulation (TMS) is a technique based on the principle of electromagnetic induction of an electric field in the brain. It has been used as a non-invasive therapy in different disorders, such as depression, bipolar disorder, Parkinson's disease, and in the rehabilitation of post-stroke aphasia. Recent studies have shown how repetitive TMS improved language characteristics in Alzheimer's disease, and there are initial data in patients with PPA.
This research project investigates the effect of repetitive TMS in patients with PPA. Investigators will perform a personalized TMS treatment for each patient (brain region, type of stimulation/inhibition, etc.), according to the specific characteristics of each patient and with the final aim to generate a computational model.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be clinically diagnosed of PPA according to current diagnostic criteria (Gorno-Tempini et al. 2011) with PET-FDG confirmation.
- •Clinical Dementia Rating 0-1.
排除标准
- •Contraindications for TMS or MRI
- •History of epilepsy
- •Pregnancy
- •Other language disorder previous to the diagnosis of PPA
- •Neuroimaging not suggestive of PPA
结局指标
主要结局
Changes in reading
时间窗: 2 months
Story and words reading test
Changes in spontaneous speech (main primary endpoint)
时间窗: 2 months (at baseline and at the end of the treatment)
Picture and story description task
Changes in oral naming
时间窗: 2 months
Object naming test
Changes in repetition
时间窗: 2 months (at baseline and at the end of the treatment)
Non-words and sentence repetition task
次要结局
- Changes in brain metabolism(2 months (at baseline and at the end of the treatment))
- Changes in brain cortical electrical activity(2 months (at baseline and at the end of the treatment))
- Changes in clinical impression of change(2 months)
- Changes in global cognition(2 months (at baseline and at the end of the study))
研究者
Jordi A Matias-Guiu
Principal Investigator. PhD MD
Hospital San Carlos, Madrid