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Completed

NCT Number: NCT03580954

Transcranial Magnetic Stimulation in Primary Progressive Aphasia

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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Key information

Conditions

Primary Progressive Aphasia Aphasia Aphasia, Primary Progressive Brain Diseases Central Nervous System Diseases Communication Disorders Dementia Language Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico San Carlos.

Madrid, 28040, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Magnetic Stimulation

Device

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Hospital San Carlos, Madrid

Other

Collaborators

  • Universidad Complutense de Madrid

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 10, 2018
Registry last updated
May 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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