Transcranial Magnetic Stimulation in Primary Progressive Aphasia

Not Applicable

Completed

• Conditions: Primary Progressive Aphasia
• Interventions: Device: Transcranial Magnetic Stimulation

• Registration Number: NCT03580954
• Lead Sponsor: Hospital San Carlos, Madrid

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2018-04-17
• Study First Submitted QC: 2018-07-06
• Study First Posted: 2018-07-10
• Primary Completion: 2020-03-10
• Study Completion: 2020-03-10
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-12
• Last Update Posted: 2020-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Repetitive TMS (inhibition)	Transcranial Magnetic Stimulation	-
Repetitive TMS (estimulation)	Transcranial Magnetic Stimulation	-

Primary Outcome Measures

Name	Time	Method
Changes in reading	2 months	Story and words reading test
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 naming	2 months	Object naming test
Changes in repetition	2 months (at baseline and at the end of the treatment)	Non-words and sentence repetition task

Secondary Outcome Measures

Name	Time	Method
Changes in brain metabolism	2 months (at baseline and at the end of the treatment)	Brain metabolism measured using 18F-FDG-PET
Changes in brain cortical electrical activity	2 months (at baseline and at the end of the treatment)	Changes in the brain cortical electrical activity measured using quantitative electroencephalography (EEG)
Changes in clinical impression of change	2 months	Caregiver's clinical impression of change (from 0 to 10)
Changes in global cognition	2 months (at baseline and at the end of the study)	Addenbrooke's Cognitive Examination III

Trial Locations

Locations (1)

Hospital Clínico San Carlos.; 🇪🇸 Madrid, Spain