Long-term Effect of 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
- 63
- 试验地点
- 2
- 主要终点
- Brain Metabolism
研究概览
简要总结
There are very few treatments for neurodegenerative disorders, and the efficacy of these treatments is generally modest. Recent studies have shown a short-term positive effect of non-invasive neuromodulation techniques such as transcranial magnetic stimulation (TMS) in primary progressive aphasia (PPA). PPA is a clinical syndrome associated with Alzheimer's disease and Frontotemporal degeneration. The aim of this study is to compare the effect of TMS and language therapy versus language therapy and sham TMS in patients with PPA during 6 months. A prospective, randomized, controlled, double-blind and parallel clinical trial will be conducted. The changes in brain metabolism using FDG-PET, language, neuropsychiatric symptoms, and daily-living activities will be assessed. Connectivity changes using electroencephalography will also be examined. In addition, a subgroup of patients will be assessed with multimodal MRI (structural and functional), and blood biomarkers. As a result of this project, valuable information about the long-term efficacy of non-invasive brain stimulation in PPA will be obtained, as well as the mechanisms of the therapy and clinical and neuroimaging factors associated with therapy response.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PPA (Gorno-Tempini et al. 2011 criteria supported by neuroimaging)
- •Language is the most prominent symptom
排除标准
- •Clinical Dementia Rating scale > 1
- •History of epilepsy or epileptiform activity in EEG
- •Another disorder causing aphasia
- •Any contraindication for TMS
- •Pregnancy
- •Medical disorder with a life expectancy of less than one year
- •Malignancy in the last two years
- •Alcohol or drug abuse
- •Major psychiatric disorder
- •Inability to communicate (mutism)
- •Use of anticonvulsants, benzodiazepines, donepezil/galantamine/rivastigmine, memantine, antidepressants and neuroleptics is permitted if they are at stable doses in the last three months.
结局指标
主要结局
Brain Metabolism
时间窗: 0 and 6 months
Changes in FDG-PET imaging (Standard Uptake Value ratio)
次要结局
- Spontaneous language(0, 3 and 6 months)
- Language assessment (Mini-Linguistic State Examination)(0, 3 and 6 months)
- Language assessment (trained words)(0, 3 and 6 months)
- Daily-living activities(0, 3 and 6 months)
- Neuropsychiatric symptoms(0, 3 and 6 months)
研究者
Jordi A Matias-Guiu
Principal Investigator
Hospital San Carlos, Madrid
