Transcranial Magnetic Stimulation in Primary Progressive Aphasia

NCT ID: NCT03580954

Last Updated: 2020-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2020-03-10

Brief Summary

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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

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Conditions

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Primary Progressive Aphasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Repetitive TMS (estimulation)

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type DEVICE

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

Repetitive TMS (inhibition)

Group Type ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type DEVICE

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

Interventions

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Transcranial Magnetic Stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Complutense de Madrid

OTHER

Sponsor Role collaborator

Hospital San Carlos, Madrid

OTHER

Sponsor Role lead

Responsible Party

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Jordi A Matias-Guiu

Principal Investigator. PhD MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital ClĂ­nico San Carlos.

Madrid, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 34487043 (View on PubMed)

Other Identifiers

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17/247-E

Identifier Type: -

Identifier Source: org_study_id

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