Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07158216

Long-term Effect of Transcranial Magnetic Stimulation and Transcranial Electrical Stimulation in Primary Progressive Aphasia: Randomized, Double-blind Clinical Trial (RECONNECT-PLUS)

Led by Hospital San Carlos, Madrid · Updated on 2026-04-23

80

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how different non-invasive brain stimulation methods affect the progression of primary progressive aphasia (PPA) over six months. The study compares three types of brain stimulation—Transcranial Magnetic Stimulation (TMS), Transcranial Direct Current Stimulation (tDCS), and a combination of both—against a sham (placebo) stimulation. All participants will also receive language therapy, as PPA mainly impacts language abilities and daily functioning. Transcranial Magnetic Stimulation follows an intermittent theta-burst protocol targeting the left dorsolateral prefrontal cortex, while Transcranial Electrical Stimulation uses an excitatory approach over the same area. Each brain stimulation session is guided by neuronavigation. Language therapy, based on the lexical retrieval cascade protocol, is provided immediately after each brain stimulation session. Treatment lasts six months, starting with an intensive period of 10 daily sessions over two weeks, followed by weekly maintenance sessions for 22 weeks. Participants will undergo assessments throughout the study, including language and cognitive tests such as the Mini-Linguistic State Examination, naming trained words, ACE-III, and neuropsychiatric inventories, all measured at six months. Brain imaging with FDG-PET will also be performed. Researchers will monitor how language abilities and daily living activities change during the study. Safety and progress will be tracked with regular evaluations to understand the long-term effects of these brain stimulation techniques on PPA.

CONDITIONS

Brief Title

Long Term Effect of Brain Stimulation in PPA

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of primary progressive aphasia (PPA) based on current consensus criteria with progressive language impairment as main cause of decline
  • Diagnosis of one of the three PPA variants (non-fluent, semantic, logopenic) supported by neuroimaging
  • Clinical Dementia Rating scale score of 1 or less
  • Language impairment is the main neurological deficit for the patient
Not Eligible

You will not qualify if you...

  • Diagnosis of conditions other than PPA causing language impairment
  • History of epilepsy or epileptiform EEG pathology
  • Contraindications for TMS or tDCS such as ferromagnetic material, pregnancy, or breastfeeding
  • Terminal illness or active cancer
  • Alcohol or substance abuse in the past year
  • Major psychiatric disorders including schizophrenia, bipolar disorder, OCD, or personality disorders
  • Absolute inability to communicate or poor language command preventing participation
  • Severe PPA preventing participation in interventions or assessments
  • Participation in another clinical trial within previous 4 months
  • Chronic use of medications that could affect study outcomes except stable antiepileptics, benzodiazepines, cholinesterase inhibitors, and SSRIs as specified

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 months

Participants receive brain stimulation sessions using transcranial magnetic or electrical stimulation combined with language therapy immediately after each session.

10 consecutive daily sessions over 2 weeks followed by weekly sessions for 22 weeks

Trial Site Locations

Total: 1 location

1

Hospital Clinico San Carlos

Madrid, Spain

Actively Recruiting

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Research Team

J

Jordi Matias-Guiu, PhD MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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Frequently Asked Questions

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Published Research Related To This Trial

Long-term effect of transcranial magnetic stimulation and transcranial electrical stimulation in primary progressive aphasia: study protocol for a randomised, double-blind clinical trial (RECONNECT-PLUS).

Lucía Fernández-Romero, María Díez-Cirarda, Cristina Delgado-Alonso...

https://pubmed.ncbi.nlm.nih.gov/42161537