Long-term Study of Brain Stimulation Combined with Language Therapy in Adults with Primary Progressive Aphasia
Led by Hospital San Carlos, Madrid · Updated on 2026-04-23
80
Participants Needed
1
Research Sites
N/A
Total Duration
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 stimulationTranscranial Magnetic Stimulation TMS, Transcranial Direct Current Stimulation tDCS, and a combination of bothagainst 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
Research Team
J
Jordi Matias-Guiu, PhD MD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
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
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
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Virtual Speech Therapy to Improve Communication and Quality of Life in Adults with Primary Progressive Aphasia and Their Partners
Long-term Study of Brain Stimulation Combined with Language Therapy in Adults with Primary Progressive Aphasia
Study of Home-Based Brain Stimulation Combined with Virtual Speech Therapy for Adults with Logopenic Variant Primary Progressive Aphasia
Tailored Speech and Language Therapy for Adults Aged 40 to 85 with Primary Progressive Aphasia
University of Pennsylvania Research Repository Collecting Data and Samples to Study Neurodegenerative Diseases
Have more questions? Get in touch with our team for quick support
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...