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

Not Applicable

Withdrawn

• Conditions: Aphasia, Primary Progressive; Repetitive Transcranical Magnetic Stimulation
• Interventions: Device: Magstim rTMS

• Registration Number: NCT03448133
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-10
• Study First Submitted QC: 2018-02-21
• Study First Posted: 2018-02-27
• Study Start: 2018-03-01
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-03
• Last Update Posted: 2020-06-05
• Primary Completion: 2021-10-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rTMS treatment group	Magstim rTMS	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
sham treatment group	Magstim rTMS	The control group is to receive sham treatment. The device is the same as the one used in the real treatment group.

Primary Outcome Measures

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

Secondary Outcome Measures

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