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临床试验/NCT05842473
NCT05842473已完成不适用

Long-term Effect of Transcranial Magnetic Stimulation in Primary Progressive Aphasia

Hospital San Carlos, Madrid2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2023年2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
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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jordi A Matias-Guiu

Principal Investigator

Hospital San Carlos, Madrid

研究点 (2)

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