CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 63 enrolled
Drug / intervention
Transcranial Magnetic Stimulation (active) +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05842473
NCT05842473N/ACompleted

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

Hospital San Carlos, Madrid·interventional·Posted May 6, 2023·Updated Dec 18, 2024

In Brief

A clinical study evaluating Transcranial Magnetic Stimulation (active), Language therapy, and 1 other intervention for Primary Progressive Aphasia and 2 related conditions. Completed, enrolled 63 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedMay 6, 2023
Enrollment StartFeb 1, 2023
Primary CompletionJul 31, 2024
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 3.2 years ago

Interventions

Transcranial Magnetic Stimulation (active)device

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 therapybehavioral

Language therapy immediately after each TMS session. Daily sessions for two weeks followed by 1 session per week.

Transcranial Magnetic Stimulation (sham)device

Theta-burst transcranial magnetic stimulation (sham) delivered over the left dorsolateral prefrontal cortex. Daily sessions for two weeks followed by 1 session per week.