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Transcranial Magnetic Stimulation in Primary Progressive Aphasia

Primary Purpose

Primary Progressive Aphasia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Sponsored by
Hospital San Carlos, Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Progressive Aphasia

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clínico San Carlos.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Repetitive TMS (estimulation)

Repetitive TMS (inhibition)

Arm Description

Outcomes

Primary Outcome Measures

Changes in spontaneous speech (main primary endpoint)
Picture and story description task
Changes in oral naming
Object naming test
Changes in reading
Story and words reading test
Changes in repetition
Non-words and sentence repetition task

Secondary Outcome Measures

Changes in brain metabolism
Brain metabolism measured using 18F-FDG-PET
Changes in clinical impression of change
Patient's clinical impression of change (from 0 to 10)
Changes in brain cortical electrical activity
Changes in the brain cortical electrical activity measured using quantitative electroencephalography (EEG)
Changes in global cognition
Addenbrooke's Cognitive Examination III
Changes in clinical impression of change
Caregiver's clinical impression of change (from 0 to 10)

Full Information

First Posted
April 17, 2018
Last Updated
May 12, 2020
Sponsor
Hospital San Carlos, Madrid
Collaborators
Universidad Complutense de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT03580954
Brief Title
Transcranial Magnetic Stimulation in Primary Progressive Aphasia
Official Title
Transcranial Magnetic Stimulation in Primary Progressive Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
March 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital San Carlos, Madrid
Collaborators
Universidad Complutense de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Progressive Aphasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Repetitive TMS (estimulation)
Arm Type
Experimental
Arm Title
Repetitive TMS (inhibition)
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation
Intervention Description
Stimulation or inhibition using TMS will be delivered guided by a neuronavigator system in different brain regions.
Primary Outcome Measure Information:
Title
Changes in spontaneous speech (main primary endpoint)
Description
Picture and story description task
Time Frame
2 months (at baseline and at the end of the treatment)
Title
Changes in oral naming
Description
Object naming test
Time Frame
2 months
Title
Changes in reading
Description
Story and words reading test
Time Frame
2 months
Title
Changes in repetition
Description
Non-words and sentence repetition task
Time Frame
2 months (at baseline and at the end of the treatment)
Secondary Outcome Measure Information:
Title
Changes in brain metabolism
Description
Brain metabolism measured using 18F-FDG-PET
Time Frame
2 months (at baseline and at the end of the treatment)
Title
Changes in clinical impression of change
Description
Patient's clinical impression of change (from 0 to 10)
Time Frame
2 months (at baseline and at the end of the treatment)
Title
Changes in brain cortical electrical activity
Description
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)
Title
Changes in global cognition
Description
Addenbrooke's Cognitive Examination III
Time Frame
2 months (at baseline and at the end of the study)
Title
Changes in clinical impression of change
Description
Caregiver's clinical impression of change (from 0 to 10)
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hospital Clínico San Carlos.
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34487043
Citation
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.
Results Reference
derived
Links:
URL
http://www.madrid.org/cs/Satellite?c=Page&cid=1142655223186&pagename=HospitalClinicoSanCarlos%2FPage%2FHCLN_contenidoFinal
Description
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Transcranial Magnetic Stimulation in Primary Progressive Aphasia

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