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CompletedNCT03580954Updated May 14, 2020

Transcranial Magnetic Stimulation in Primary Progressive Aphasia

An interventional study of Transcranial Magnetic Stimulation in Primary Progressive Aphasia, sponsored by Hospital San Carlos, Madrid. Completed at 1 site in Spain. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2020-05-14.

Sponsored by Hospital San Carlos, Madrid · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
45 Years and older
Sex
All
01

Study 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.

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Conditions studied

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In context

Aphasia

365 studies on the registry are indexed under Aphasia; 89 are open to participants now.

This study's enrollment of 20 is below the median of 30 across 316 interventional studies indexed under Aphasia.

Browse Aphasia studies →

Lead sponsor

Hospital San Carlos, Madrid is the lead sponsor of 70 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Repetitive TMS (estimulation)

    Device: Transcranial Magnetic Stimulation

  • Active comparator
    Repetitive TMS (inhibition)

    Device: Transcranial Magnetic Stimulation

Interventions

  • DeviceTranscranial Magnetic Stimulation

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

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What researchers measure

Primary outcomes

  1. Changes in spontaneous speech (main primary endpoint)

    Picture and story description task

    Time frame: 2 months (at baseline and at the end of the treatment)

  2. Changes in oral naming

    Object naming test

    Time frame: 2 months

  3. Changes in reading

    Story and words reading test

    Time frame: 2 months

  4. Changes in repetition

    Non-words and sentence repetition task

    Time frame: 2 months (at baseline and at the end of the treatment)

Secondary outcomes

  1. Changes in brain metabolism

    Brain metabolism measured using 18F-FDG-PET

    Time frame: 2 months (at baseline and at the end of the treatment)

  2. Changes in clinical impression of change

    Patient's clinical impression of change (from 0 to 10)

    Time frame: 2 months (at baseline and at the end of the treatment)

  3. Changes in brain cortical electrical activity

    Changes in the brain cortical electrical activity measured using quantitative electroencephalography (EEG)

    Time frame: 2 months (at baseline and at the end of the treatment)

  4. Changes in global cognition

    Addenbrooke's Cognitive Examination III

    Time frame: 2 months (at baseline and at the end of the study)

  5. Changes in clinical impression of change

    Caregiver's clinical impression of change (from 0 to 10)

    Time frame: 2 months

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Study locations

1 site
  • Hospital Clínico San Carlos.
    Madrid, 28040, Spain
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References and documents

Publications

  • 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. PubMed 34487043 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03580954
Lead sponsor
Hospital San Carlos, Madrid
Collaborators
Universidad Complutense de Madrid
Responsible party
Jordi A Matias-Guiu (Principal Investigator. PhD MD, Hospital San Carlos, Madrid) — Principal investigator
First posted
Jul 10, 2018
Start date
Feb 1, 2018
Primary completion
Mar 10, 2020
Completion
Mar 10, 2020
Last update
May 14, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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