Clinical trial NCT03580954: Transcranial Magnetic Stimulation in Primary Progressive Aphasia
Official title: Transcranial Magnetic Stimulation in Primary Progressive Aphasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Progressive Aphasia
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
Collaborators: name: Universidad Complutense de Madrid
First posted: 2018-07-10
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in spontaneous speech (main primary endpoint)
timeFrame: 2 months (at baseline and at the end of the treatment)
measure: Changes in oral naming
timeFrame: 2 months
measure: Changes in reading
timeFrame: 2 months
measure: Changes in repetition
timeFrame: 2 months (at baseline and at the end of the treatment)
Secondary outcomes:
measure: Changes in brain metabolism
timeFrame: 2 months (at baseline and at the end of the treatment)
measure: Changes in clinical impression of change
timeFrame: 2 months (at baseline and at the end of the treatment)
measure: Changes in brain cortical electrical activity
timeFrame: 2 months (at baseline and at the end of the treatment)
measure: Changes in global cognition
timeFrame: 2 months (at baseline and at the end of the study)
measure: Changes in clinical impression of change
timeFrame: 2 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos.
Study officials:
References:
citation: Pytel V, Cabrera-Martin MN, Delgado-Alvarez A, Ayala JL, Balugo P, Delgado-Alonso C, Yus M, Carreras MT, Carreras JL, Matias-Guiu J, Matias-Guiu JA. Personalized Repetitive Transcranial Magnetic Stimulation for Primary Progressive Aphasia. J Alzheimers Dis. 2021;84(1):151-167. doi: 10.3233/JAD-210566.