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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

Primary Progressive Aphasia(PPA)

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

Plain Language Summary

Simplified for easier understanding

This study examines whether long-term brain stimulation treatments (non-invasive techniques called TMS and tDCS) can slow or improve language decline in people with Primary Progressive Aphasia (PPA) — a rare neurological condition that gradually destroys a person's ability to speak, read, and write. **You may be eligible if...** - You have been diagnosed with Primary Progressive Aphasia (PPA), confirmed by brain imaging - Your cognitive decline is mild to moderate (Clinical Dementia Rating of 1 or less) - Language difficulty is your primary neurological symptom **You may NOT be eligible if...** - You have a different condition causing your language problems - You have epilepsy or abnormal electrical activity in your brain (EEG) - You have metal implants, are pregnant, or breastfeeding (contraindications to TMS/tDCS) - You have a serious psychiatric disorder such as schizophrenia or bipolar disorder - Your PPA is so severe you are unable to communicate at all (mutism) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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