NCT07158216

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Hospital San Carlos, Madrid · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Primary Progressive Aphasia(PPA)

Interventions

Type	Name	Description
DEVICE	TMS	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)
DEVICE	tDCS	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)
DEVICE	Sham 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)
DEVICE	Sham 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)

Timeline

• Start date: 2025-09-15
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2025-09-05
• Last updated: 2025-09-11

Locations

1 site across 1 country: Spain