Status:
RECRUITING
Long Term Effect of Brain Stimulation in PPA
Lead Sponsor:
Hospital San Carlos, Madrid
Conditions:
Primary Progressive Aphasia(PPA)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to investigate the effect of non-invasive brain stimulation techniques in the progression of primary progressive aphasia for 6 months. We will compare three modaliti...
Detailed Description
Transcranial Magnetic Stimulation will follow an intermitent theta-burst protocol targetting the left dorsolateral prefrontal cortex. Transcranial electrical stimulation will also follow an excitatory...
Eligibility Criteria
Inclusion
- Diagnosis of PPA according to the current consensus criteria supported by neuroimaging (FDG-PET or MRI) (Gorno-Tempini et al., 2011);
- Clinical Dementia Rating scale equal or less than 1;
- The language impairment is the main neurological deficit for the patient.
Exclusion
- Patient diagnosed with a condition other than PPA that could cause language impairment;
- History of epilepsy or presence of focal epileptiform pathology on EEG recording; ·Contraindications related to the treatments or procedures to be used (TMS and tDCS), such as ferromagnetic material, pregnancy, or breastfeeding;
- Terminal illness or active malignancy;
- Alcohol or substance abuse within the past year;
- Major psychiatric disorders (schizophrenia, schizoaffective disorders, bipolar disorder, obsessive-compulsive disorder, or personality disorders);
- Absolute inability to communicate (mutism), or poor command of the language that, in the investigator's judgment, would prevent participation in the study;
- Severity of PPA that prevents participation in interventions or assessments at the time of inclusion;
- Participation in another clinical trial within the previous 4 months;
- Chronic use of medications that could affect study outcomes;
- Antiepileptic drugs: allowed if on stable doses for at least 3 months before inclusion. If needed during the study due to seizure occurrence, they may be added;
- Diazepam and derivatives: permitted only if on stable doses for at least 3 months before inclusion. Dose adjustments during the study are allowed;
- Donepezil, Galantamine, Rivastigmine, and Memantine: allowed if on stable doses for at least 3 months before inclusion;
- SSRIs (Selective Serotonin Reuptake Inhibitors): permitted only if on stable doses for at least 3 months prior to inclusion. If necessary during the study, they may be added;
- Medications that may lower the seizure threshold (e.g., tricyclic antidepressants, antipsychotics): allowed if on stable doses for at least 3 months before inclusion.
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07158216
Start Date
September 15 2025
End Date
December 1 2028
Last Update
September 11 2025
Active Locations (1)
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1
Hospital Clinico San Carlos
Madrid, Spain