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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
63
Theta-burst transcranial magnetic stimulation (active) delivered over the left dorsolateral prefrontal cortex. Daily sessions for two weeks followed by 1 session per week.
Language therapy immediately after each TMS session. Daily sessions for two weeks followed by 1 session per week.
Theta-burst transcranial magnetic stimulation (sham) delivered over the left dorsolateral prefrontal cortex. Daily sessions for two weeks followed by 1 session per week.
Hospital Clínico San Carlos.
Madrid, Madrid, Spain
Brain Metabolism
Changes in FDG-PET imaging (Standard Uptake Value ratio)
Time frame: 0 and 6 months
Spontaneous language
Changes in Words per minute
Time frame: 0, 3 and 6 months
Language assessment (Mini-Linguistic State Examination)
Changes in Mini-Linguistic State Examination test
Time frame: 0, 3 and 6 months
Language assessment (trained words)
Changes in trained words accuracy (number of words)
Time frame: 0, 3 and 6 months
Daily-living activities
Changes in Interview for Deterioration in Daily living in Dementia Scale
Time frame: 0, 3 and 6 months
Neuropsychiatric symptoms
Changes in Neuropsychiatric Inventory scale
Time frame: 0, 3 and 6 months
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