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Long Term Effect of Brain Stimulation in PPA

NCT07158216 · Hospital San Carlos, Madrid
In plain English

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Official title
LONG-TERM EFFECT OF TRANSCRANIAL MAGNETIC STIMULATION AND TRANSCRANIAL ELECTRICAL STIMULATION IN PRIMARY PROGRESSIVE APHASIA: RANDOMIZED, DOUBLE-BLIND CLINICAL TRIAL (RECONNECT-PLUS)
About this study
Transcranial Magnetic Stimulation will follow an intermitent theta-burst protocol targetting the left dorsolateral prefrontal cortex. Transcranial electrical stimulation will also follow an excitatory protocol over the same region. All brain stimulation procedures will be conducted under neuronavigation. Language therapy will follow the lexical retrieval cascade protocol and will be conducted after each brain stimulation session.
Eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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.
Study design
Enrollment target: 80 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-09-15
Estimated completion: 2028-12
Last updated: 2025-09-11
Interventions
Device: TMSDevice: tDCSDevice: Sham TMSDevice: Sham tDCS
Primary outcomes
  • Mini-Linguistic State Examination (6 months)
Sponsor
Hospital San Carlos, Madrid · other
Contacts & investigators
ContactJordi Matias-Guiu, PhD MD · contact · jordi.matias-guiu@salud.madrid.org · +34913303000
All locations (1)
Hospital Clinico San CarlosRecruiting
Madrid, Spain
Long Term Effect of Brain Stimulation in PPA · TrialPath