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Transcranial Magnetic Stimulation in Primary Progressive Aphasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03580954
Recruitment Status : Completed
First Posted : July 10, 2018
Last Update Posted : May 14, 2020
Sponsor:
Collaborator:
Universidad Complutense de Madrid
Information provided by (Responsible Party):
Jordi A Matias-Guiu, 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.


Condition or disease Intervention/treatment Phase
Primary Progressive Aphasia Device: Transcranial Magnetic Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation in Primary Progressive Aphasia
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : March 10, 2020
Actual Study Completion Date : March 10, 2020


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.




Primary Outcome Measures :
  1. 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. Changes in oral naming [ Time Frame: 2 months ]
    Object naming test

  3. Changes in reading [ Time Frame: 2 months ]
    Story and words reading test

  4. Changes in repetition [ Time Frame: 2 months (at baseline and at the end of the treatment) ]
    Non-words and sentence repetition task


Secondary Outcome Measures :
  1. 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. 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)

  3. 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)

  4. Changes in global cognition [ Time Frame: 2 months (at baseline and at the end of the study) ]
    Addenbrooke's Cognitive Examination III

  5. Changes in clinical impression of change [ Time Frame: 2 months ]
    Caregiver's clinical impression of change (from 0 to 10)



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580954


Locations
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Spain
Hospital Clínico San Carlos.
Madrid, Spain, 28040
Sponsors and Collaborators
Hospital San Carlos, Madrid
Universidad Complutense de Madrid
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jordi A Matias-Guiu, Principal Investigator. PhD MD, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier: NCT03580954    
Other Study ID Numbers: 17/247-E
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aphasia
Aphasia, Primary Progressive
Pick Disease of the Brain
Frontotemporal Dementia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Dementia
Brain Diseases
Central Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
Metabolic Diseases