Transcranial Magnetic Stimulation in Primary Progressive Aphasia

Primary Progressive Aphasia Clinical Trial

Official title:

Transcranial Magnetic Stimulation in Primary Progressive Aphasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03580954
• Other study ID #: 17/247-E
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: March 10, 2020

Study information

• Verified date: May 2020
• Source: Hospital San Carlos, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 10, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Primary Progressive
• Frontotemporal Dementia
• Pick Disease of the Brain
• Primary Progressive Aphasia

Intervention

Device:
• Transcranial Magnetic Stimulation
Stimulation or inhibition using TMS will be delivered guided by a neuronavigator system in different brain regions.

Locations

Country	Name	City	State
Spain	Hospital Clínico San Carlos.	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid	Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in spontaneous speech (main primary endpoint)	Picture and story description task	2 months (at baseline and at the end of the treatment)
Primary	Changes in oral naming	Object naming test	2 months
Primary	Changes in reading	Story and words reading test	2 months
Primary	Changes in repetition	Non-words and sentence repetition task	2 months (at baseline and at the end of the treatment)
Secondary	Changes in brain metabolism	Brain metabolism measured using 18F-FDG-PET	2 months (at baseline and at the end of the treatment)
Secondary	Changes in clinical impression of change	Patient's clinical impression of change (from 0 to 10)	2 months (at baseline and at the end of the treatment)
Secondary	Changes in brain cortical electrical activity	Changes in the brain cortical electrical activity measured using quantitative electroencephalography (EEG)	2 months (at baseline and at the end of the treatment)
Secondary	Changes in global cognition	Addenbrooke's Cognitive Examination III	2 months (at baseline and at the end of the study)
Secondary	Changes in clinical impression of change	Caregiver's clinical impression of change (from 0 to 10)	2 months

External Links

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