rTMS for the Treatment of Primary Progressive Aphasia: A Randomized Controlled Trial

Repetitive Transcranial Magnetic Stimulation for the Treatment of Primary Progressive Aphasia: A Randomized Controlled Tria

The primary progressive aphasia (PPA) is a neurodegenerative condition characterized by a gradual, irreversible decline of language function (Mesulam, 2001). There are no known treatments for PPA so far. The relentless progression of PPA symptoms eventually leads to a profound impairment in communication ability and, ultimately, to more generalized deficits of cognition. Some cases and small studies reported that Transcranial Magnetic Stimulation (TMS), one of the non-invasive neuromodulation tech, can be employed to facilitate language production and improve the language ability in patients with PPA. Herein we will explore the tolerance and efficacy of TMS for the treatment of PPA by the randomized controlled trial .Meanwhile the functional MRI tech will be used to investigate the neural network changing in the procedure

Study Overview

• Status: Withdrawn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

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

All participants had also been evaluated previously by a behavioral neurologist at the Peking Union Medical College Hospital and had been clinically diagnosed with a variant of PPA.

Exclusion Criteria:

1. Scored below 15 on the mini-mental state exam (MMSE) due to concerns that global cognitive impairment might preclude their ability to follow the directions and interfere with task performance.
2. Had a history of seizures or unexplained loss of consciousness, pregnancy, surgical breach of the skull, or any other medical or surgical contraindication to receiving noninvasive brain stimulation.
3. Is unable to complete the treatment and evaluations

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
Experimental: rTMS treatment group; The participants will be devided into rTMS treatment and sham treatment by means of randomized methods.The protocol of 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston naming test evaluation	Assessment of the language production	Baseline
Boston naming test evaluation	Assessment of the language production	One month(just after 20 times rTMS treatment)
Western Aphasia Battery(WAB) Speech fluency	Assessment of the language production	Baseline
Western Aphasia Battery(WAB) Speech fluency	Assessment of the language production	One month(just after 20 times rTMS treatment)
Repetition Part of WAB	Assessment of the repetition ability	Baseline
Repetition Part of WAB	Assessment of the repetition ability	One month(just after 20 times rTMS treatment)
Word recognition Part of WAB	Assessment of the reading	Baseline
Word recognition Part of WAB	Assessment of the reading	One month(just after 20 times rTMS treatment)
Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version)	Assessment of the grammar ability	Baseline
Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version)	Assessment of the grammar ability	One month(just after 20 times rTMS treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length)	Graph theoretical analysis of the speech/language network	Baseline
fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length)	Graph theoretical analysis of the speech/language network	One month(just after 20 times rTMS treatment)

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2018
• Primary Completion (Anticipated): October 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: February 10, 2018
• First Submitted That Met QC Criteria: February 21, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): June 5, 2020
• Last Update Submitted That Met QC Criteria: June 3, 2020
• Last Verified: June 1, 2020

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: rTMSPPA-PUMCH

Drug and device information, study documents

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