NCT05842473Completed
Long-term Effect of TMS in Primary Progressive Aphasia
Long-term Effect of Transcranial Magnetic Stimulation in Primary Progressive Aphasia
Source: ClinicalTrials.gov · Last updated 18 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 63 (actual)
- First submitted
- 24 Apr 2023
- Start date
- 1 Feb 2023
- Primary completion date
- 31 Jul 2024
- Lead sponsor
- Hospital San Carlos, Madrid
- Diseases
- Frontotemporal dementia, Alzheimer disease
- NCT number
- NCT05842473
What you commit to
- Study type: Interventional
- Participants enrolled: 63
- From 1 Feb 2023 to the primary completion date, 31 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Alcohol or drug abuse
Other illness
- Clinical Dementia Rating scale \> 1
- History of epilepsy or epileptiform activity in EEG
- Another disorder causing aphasia
- Medical disorder with a life expectancy of less than one year
- Malignancy in the last two years
- Major psychiatric disorder
Other
- Any contraindication for TMS
- Pregnancy
- 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.
Who the study is looking for
- Diagnosis of PPA (Gorno-Tempini et al. 2011 criteria supported by neuroimaging)
- CDR
- Language is the most prominent symptom
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.