NCT05842473

Long-term Effect of TMS in Primary Progressive Aphasia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Hospital San Carlos, Madrid · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Primary Progressive Aphasia
• Frontotemporal Dementia
• Alzheimer Disease

Interventions

Type	Name	Description
DEVICE	Transcranial Magnetic Stimulation (active)	Theta-burst transcranial magnetic stimulation (active) delivered over the left dorsolateral prefrontal cortex. Daily sessions for two weeks followed by 1 session per week.
BEHAVIORAL	Language therapy	Language therapy immediately after each TMS session. Daily sessions for two weeks followed by 1 session per week.
DEVICE	Transcranial Magnetic Stimulation (sham)	Theta-burst transcranial magnetic stimulation (sham) delivered over the left dorsolateral prefrontal cortex. Daily sessions for two weeks followed by 1 session per week.

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2023-05-06
• Last updated: 2024-12-18

Locations

1 site across 1 country: Spain