Transcranial Magnetic Stimulation in Primary Progressive Aphasia

• ClinicalTrials.gov Identifier: NCT03580954
• Recruitment Status: Completed
• First Posted: July 10, 2018
• Last Update Posted: May 14, 2020
• Sponsor: Hospital San Carlos, Madrid
• Collaborator: Universidad Complutense de Madrid
• Information provided by (Responsible Party): Jordi A Matias-Guiu, Hospital San Carlos, Madrid

Tracking Information

• First Submitted Date: April 17, 2018
• First Posted Date: July 10, 2018
• Last Update Posted Date: May 14, 2020
• Actual Study Start Date: February 1, 2018
• Actual Primary Completion Date: March 10, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 12, 2020)

• 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
• Changes in oral naming [ Time Frame: 2 months ]
  Object naming test
• Changes in reading [ Time Frame: 2 months ]
  Story and words reading test
• Changes in repetition [ Time Frame: 2 months (at baseline and at the end of the treatment) ]
  Non-words and sentence repetition task

Original Primary Outcome Measures (submitted: July 6, 2018)

• Changes in oral naming [ Time Frame: 2 months ]
  Object naming test
• Changes in reading [ Time Frame: 2 months ]
  Story and words reading test
• Changes in spontaneous speech [ Time Frame: 2 months (at baseline and at the end of the treatment) ]
  Picture and story description task
• Changes in repetition [ Time Frame: 2 months (at baseline and at the end of the treatment) ]
  Non-words and sentence repetition task

Current Secondary Outcome Measures (submitted: July 9, 2018)

• Changes in brain metabolism [ Time Frame: 2 months (at baseline and at the end of the treatment) ]
  Brain metabolism measured using 18F-FDG-PET
• 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)
• 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)
• Changes in global cognition [ Time Frame: 2 months (at baseline and at the end of the study) ]
  Addenbrooke's Cognitive Examination III
• Changes in clinical impression of change [ Time Frame: 2 months ]
  Caregiver's clinical impression of change (from 0 to 10)

Original Secondary Outcome Measures (submitted: July 6, 2018)

• Changes in brain metabolism [ Time Frame: 2 months (at baseline and at the end of the treatment) ]
  Brain metabolism measured using 18F-FDG-PET
• Changes in clinical impression of change [ Time Frame: 2 months (at baseline and at the end of the treatment) ]
  Patient's and caregiver's clinical impression of change
• 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)
• Changes in global cognition [ Time Frame: 2 months (at baseline and at the end of the study) ]
  Addenbrooke's Cognitive Examination III

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Transcranial Magnetic Stimulation in Primary Progressive Aphasia
• Official Title: Transcranial Magnetic Stimulation in Primary Progressive Aphasia

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: 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.

Study Arms

• Experimental: Repetitive TMS (estimulation)
  Intervention: Device: Transcranial Magnetic Stimulation
• Active Comparator: Repetitive TMS (inhibition)
  Intervention: Device: Transcranial Magnetic Stimulation

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 12, 2020): 20
• Original Estimated Enrollment (submitted: July 6, 2018): 15
• Actual Study Completion Date: March 10, 2020
• Actual Primary Completion Date: March 10, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 45 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT03580954
• Other Study ID Numbers: 17/247-E
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Jordi A Matias-Guiu, Hospital San Carlos, Madrid
• Original Responsible Party: Same as current
• Current Study Sponsor: Hospital San Carlos, Madrid
• Original Study Sponsor: Same as current
• Collaborators: Universidad Complutense de Madrid
• Investigators: Not Provided
• PRS Account: Hospital San Carlos, Madrid
• Verification Date: May 2020