rTMS Treatment of Primary Progressive Aphasia

Repetitive Transcranial Magnetic Stimulation in the Treatment of Primary Progressive Aphasia: A Randomized Controlled Trial

Primary Progressive Aphasia (PPA) is a neurodegenerative disease in which language function is gradually and progressively impaired. Patients will eventually be disabled in communication and have cognition deficits, which put a heavy burden not only on their families but also on the whole society. However, no effective treatment for PPA has been explored so far. The current clinical randomized trial is to study the safety and efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) for the treatment of PPA. Also, multi-modality of neuroimaging techniques, such as functional MRI and PET will be used to investigate brain network changing in this procedure.

Study Overview

• Status: Completed
• Conditions: Primary Progressive Aphasia; Repetitive Transcranical Magnetic Stimulation
• Intervention / Treatment: Device: Magstim rTMS

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuzhou Guan; Phone Number: 8613910081750; Email: guanyz001@163.com
• Study Contact Backup: Name: Caiyan Liu; Phone Number: 8618601017840; Email: liucy-pumch@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Clinical diagnosis of PPA

Exclusion Criteria:

• Scored below 15 on the mini-mental state exam (MMSE)
• history of seizures or unexplained loss of consciousness
• pregnancy
• surgical breach of the skull
• MRI contraindication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: sham treatment group; The control group is to receive sham treatment. The device is the same as the one used in the real treatment group.	Device: Magstim rTMS; The device is made in London,UK
Experimental: rTMS treatment group; The participants will be divided into the rTMS treatment group and the sham treatment group by means of randomized methods.The protocol of the treatment is to use rTMS with high frequency 10/20Hz 120%RMT 20 times for one month. The device is Magtism rTMS made in London, UK	Device: Magstim rTMS; The device is made in London,UK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston naming test evaluation	Assessment of the language production. Scores range from 0 to 30. Higher scores means better outcome.	1 day before the treatment
Boston naming test evaluation	Assessment of the language production. Scores range from 0 to 30. Higher scores means better outcome.	1 month, 3 months and 6 months after the treatment
Western Aphasia Battery (WAB) Speech fluency	Assessment of the language production. Scores range from 0 to 20. Higher scores means better outcome.	1 day before the treatment
Western Aphasia Battery (WAB) Speech fluency	Assessment of the language production. Scores range from 0 to 20. Higher scores means better outcome.	1 month, 3 months and 6 months after the treatment
Western Aphasia Battery (WAB) Repetition	Assessment of the repetition ability. Scores range from 0 to 100. Higher scores means better outcome.	1 day before the treatment
Western Aphasia Battery (WAB) Repetition	Assessment of the repetition ability. Scores range from 0 to 100. Higher scores means better outcome.	1 month, 3 months and 6 months after the treatment
Western Aphasia Battery (WAB) Word recognition	Assessment of the reading. Scores range from 0 to 60. Higher scores means better outcome.	1 day before the treatment
Western Aphasia Battery (WAB) Word recognition	Assessment of the reading. Scores range from 0 to 60. Higher scores means better outcome.	1 month, 3 months and 6 months after the treatment
Syntax comprehension part of Bilingual aphasia test (Standard Modern Chinese Version)	Assessment of the grammar ability. Scores range from 0 to 50. Higher scores means better outcome.	1 day before the treatment
Syntax comprehension part of Bilingual aphasia test (Standard Modern Chinese Version)	Assessment of the grammar ability. Scores range from 0 to 50. Higher scores means better outcome.	1 month, 3 months and 6 months after the treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional connectivity map (FC map)	Functional Connectivity was examined using a seed-based voxel-wise correlation approach. The language related brain areas, such as Broca Area and Wernicke Area, were defined as the regions of interest (ROI). Pearson's correlation analysis between the time course of the ROI and that of every voxel in the whole brain was computed for a map of correlation coefficients, which were Fisher's z-transformed and called as z-FC maps. This outcome measurement, the z-FC map, is not numeric data. Z-FC map is a radiographic imaging measurement.	1 day before the treatment
functional connectivity map (FC map)	Functional Connectivity was examined using a seed-based voxel-wise correlation approach. The language related brain areas, such as Broca Area and Wernicke Area, were defined as the regions of interest (ROI). Pearson's correlation analysis between the time course of the ROI and that of every voxel in the whole brain was computed for a map of correlation coefficients, which were Fisher's z-transformed and called as z-FC maps. This outcome measurement, the z-FC map, is not numeric data. Z-FC map is a radiographic imaging measurement.	1 month, 3 months and 6 months after the treatment
Standardized Uptake Value (SUV)	PET parameter to evaluate brain metabolism	1 day before the treatment
Standardized Uptake Value (SUV)	PET parameter to evaluate brain metabolism	1 month, 3 months and 6 months after the treatment

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Dementia; Language Disorders; Communication Disorders; Speech Disorders; Frontotemporal Lobar Degeneration; Aphasia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
• Other Study ID Numbers: PPA-rTMS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No