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Transcranial Magnetic Stimulation in Primary Progressive Aphasia

Transcranial Magnetic Stimulation in Primary Progressive Aphasia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03580954
Enrollment
20
Registered
2018-07-10
Start date
2018-02-01
Completion date
2020-03-10
Last updated
2020-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Progressive Aphasia

Brief summary

Primary progressive aphasia (PPA) is a clinical syndrome characterized by the neurodegeneration of language brain systems. Three main clinical variants are currently recorgnized (nonfluent, semantic, and logopenic PPA). Nowadays, there are no effective treatments for this disorder. Transcranial Magnetic Stimulation (TMS) is a technique based on the principle of electromagnetic induction of an electric field in the brain. It has been used as a non-invasive therapy in different disorders, such as depression, bipolar disorder, Parkinson's disease, and in the rehabilitation of post-stroke aphasia. Recent studies have shown how repetitive TMS improved language characteristics in Alzheimer's disease, and there are initial data in patients with PPA. This research project investigates the effect of repetitive TMS in patients with PPA. Investigators will perform a personalized TMS treatment for each patient (brain region, type of stimulation/inhibition, etc.), according to the specific characteristics of each patient and with the final aim to generate a computational model.

Interventions

DEVICETranscranial Magnetic Stimulation

Stimulation or inhibition using TMS will be delivered guided by a neuronavigator system in different brain regions.

Sponsors

Universidad Complutense de Madrid
CollaboratorOTHER
Hospital San Carlos, Madrid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Must be clinically diagnosed of PPA according to current diagnostic criteria (Gorno-Tempini et al. 2011) with PET-FDG confirmation. * Clinical Dementia Rating 0-1.

Exclusion criteria

* Contraindications for TMS or MRI * History of epilepsy * Pregnancy * Other language disorder previous to the diagnosis of PPA * Neuroimaging not suggestive of PPA

Design outcomes

Primary

MeasureTime frameDescription
Changes in repetition2 months (at baseline and at the end of the treatment)Non-words and sentence repetition task
Changes in spontaneous speech (main primary endpoint)2 months (at baseline and at the end of the treatment)Picture and story description task
Changes in oral naming2 monthsObject naming test
Changes in reading2 monthsStory and words reading test

Secondary

MeasureTime frameDescription
Changes in brain metabolism2 months (at baseline and at the end of the treatment)Brain metabolism measured using 18F-FDG-PET
Changes in clinical impression of change2 months (at baseline and at the end of the treatment)Patient's clinical impression of change (from 0 to 10)
Changes in brain cortical electrical activity2 months (at baseline and at the end of the treatment)Changes in the brain cortical electrical activity measured using quantitative electroencephalography (EEG)
Changes in global cognition2 months (at baseline and at the end of the study)Addenbrooke's Cognitive Examination III

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026