Long Term Effect of Brain Stimulation in PPA

NCT07158216 | Recruiting

• 1 other identifier: Hospital Clinico San Carlos
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Primary Progressive Aphasia(PPA)

Keywords

Primary progressive aphasia; Frontotemporal dementia; Alzheimer's disease; Brain stimulation; Transcranial Magnetic Stimulation; Transcranial direct current stimulation; Transcranial electrical stimulation

Outcome Measures

Primary Outcomes (1)

• Mini-Linguistic State Examination

  6 months

Secondary Outcomes (7)

• Naming of trained words

  6 monhts

• ACE-III

  6 months

• Interview for Deterioration in Daily Living Activities in Dementia (IDDD)

  6 months

• Communicative Effectiveness Index (CETI)

  6 months

• CDR(R) plus NACC FTLD-SB

  6 months

Study Arms (4)

active TMS + active tDCS

EXPERIMENTAL

Device: TMS; Device: tDCS

active TMS + sham tDCS

EXPERIMENTAL

Device: TMS; Device: Sham tDCS

sham TMS + active tDCS

EXPERIMENTAL

Device: tDCS; Device: Sham TMS

sham TMS + sham tDCS

SHAM COMPARATOR

Device: Sham TMS; Device: Sham tDCS

Interventions

TMS DEVICE

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)

active TMS + active tDCS; active TMS + sham tDCS

tDCS DEVICE

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)

active TMS + active tDCS; sham TMS + active tDCS

Sham TMS DEVICE

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)

sham TMS + active tDCS; sham TMS + sham tDCS

Sham tDCS DEVICE

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)

active TMS + sham tDCS; sham TMS + sham tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Participation in another clinical trial within the previous 4 months;
• Chronic use of medications that could affect study outcomes;

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead

Study Sites (1)

Hospital Clinico San Carlos

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Aphasia, Primary Progressive; Frontotemporal Dementia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Jordi Matias-Guiu, PhD MD

CONTACT

+34913303000; jordi.matias-guiu@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both outcome assessors and participants will be blinded to the assigned treatment. Only the technicians administering TMS will be aware of the brain stimulation assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD Neurologist

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

ES (1)