Transcranial Magnetic Stimulation in Primary Progressive Aphasia

May 12, 2020 updated by: Jordi A Matias-Guiu, Hospital San Carlos, Madrid

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Hospital Clínico San Carlos.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Repetitive TMS (estimulation)
Device: Transcranial Magnetic Stimulation
Stimulation or inhibition using TMS will be delivered guided by a neuronavigator system in different brain regions.
Active Comparator: Repetitive TMS (inhibition)
Device: Transcranial Magnetic Stimulation
Stimulation or inhibition using TMS will be delivered guided by a neuronavigator system in different brain regions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in spontaneous speech (main primary endpoint)
Time Frame: 2 months (at baseline and at the end of the treatment)
Picture and story description task
2 months (at baseline and at the end of the treatment)
Changes in oral naming
Time Frame: 2 months
Object naming test
2 months
Changes in reading
Time Frame: 2 months
Story and words reading test
2 months
Changes in repetition
Time Frame: 2 months (at baseline and at the end of the treatment)
Non-words and sentence repetition task
2 months (at baseline and at the end of the treatment)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital San Carlos, Madrid

Collaborators

Universidad Complutense de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

March 10, 2020

Study Completion (Actual)

March 10, 2020

Study Registration Dates

First Submitted

April 17, 2018

First Submitted That Met QC Criteria

July 6, 2018

First Posted (Actual)

July 10, 2018

Study Record Updates

Last Update Posted (Actual)

May 14, 2020

Last Update Submitted That Met QC Criteria

May 12, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17/247-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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