RecruitingNot ApplicableNCT07158216

Long Term Effect of Brain Stimulation in PPA

LONG-TERM EFFECT OF TRANSCRANIAL MAGNETIC STIMULATION AND TRANSCRANIAL ELECTRICAL STIMULATION IN PRIMARY PROGRESSIVE APHASIA: RANDOMIZED, DOUBLE-BLIND CLINICAL TRIAL (RECONNECT-PLUS)


Sponsor

Hospital San Carlos, Madrid

Enrollment

80 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

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 modalities of brain stimulation (TMS, tDCS, TMS+tDCS) against sham stimulation. All patients will receive also language therapy.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria14

  • 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.

Interventions

DEVICETMS

Active TMS + sham tDCS. All patients will receive language therapy immediately after brain stimulation. The period of treatment will be 6 months, comprising 10 consecutive sessions in two weeks (intensive period) followed by once per week (maintenance period of 22 weeks)

DEVICEtDCS

sham TMS + active tDCS. All patients will receive language therapy immediately after brain stimulation. The period of treatment will be 6 months, comprising 10 consecutive sessions in two weeks (intensive period) followed by once per week (maintenance period of 22 weeks)

DEVICESham TMS

Sham TMS. All patients will receive language therapy immediately after brain stimulation. The period of treatment will be 6 months, comprising 10 consecutive sessions in two weeks (intensive period) followed by once per week (maintenance period of 22 weeks)

DEVICESham tDCS

Sham tDCS. All patients will receive language therapy immediately after brain stimulation. The period of treatment will be 6 months, comprising 10 consecutive sessions in two weeks (intensive period) followed by once per week (maintenance period of 22 weeks)


Locations(1)

Hospital Clinico San Carlos

Madrid, Spain

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NCT07158216


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