Long-term brain stimulation for primary progressive aphasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with a consensus diagnosis of primary progressive aphasia will be randomized to receive intermittent theta-burst TMS, excitatory tDCS, combined TMS+tDCS, or sham stimulation, with all groups receiving the same language therapy. Stimulation targets the left dorsolateral prefrontal cortex using neuronavigation, and language therapy follows a lexical retrieval cascade protocol delivered after each stimulation session. Outcomes will track language performance and progression over a six-month period to compare active modalities against sham. The protocol is interventional and focused on non-invasive neuromodulation paired with standardized speech-language therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of PPA according to the current consensus criteria proposed by Gorno-Tempini et al., 2011), based on the presence of progressive language impairment as the most prominent and primary cause of functional decline and the exclusion of other medical, psychiatric, or non-neurodegenerative causes,a s well as early prominent memory, visuoperceptual or behavioral disturbances;
* Diagnosis of one of the three variants of PPA (non-fluent, semantic, or logopenic) according to the consensus criteria (Gorno-Tempini et al., 2011), based on the language profile and supported by neuroimaging (FDG-PET or MRI).
* 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.

Where it's running

• Hospital Clinico San Carlos
  Madrid, Spain Recruiting

Study contacts

• Study coordinator: Jordi Matias-Guiu, PhD MD
• Email: jordi.matias-guiu@salud.madrid.org
• Phone: +34913303000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Home-based brain stimulation with virtual speech therapy for logopenic PPA

  This project will test whether home-based transcranial direct current stimulation (tDCS) combined with virtual speech-language therapy helps people with the logopenic variant of primary progressive aphasia communicate better.

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• Personalized virtual speech therapy to improve communication in primary progressive aphasia

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.