rTMS Treatment of Primary Progressive Aphasia

Not Applicable

Completed

• Conditions: Repetitive Transcranical Magnetic Stimulation; Primary Progressive Aphasia

• Registration Number: NCT04431401
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-11
• Study First Posted: 2020-06-16
• Study Start: 2020-07-01
• Primary Completion: 2022-07-01
• Study Completion: 2022-08-31
• Status Verified: 2023-03
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
functional connectivity map (FC map)	1 month, 3 months and 6 months after the treatment	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.
Standardized Uptake Value (SUV)	1 month, 3 months and 6 months after the treatment	PET parameter to evaluate brain metabolism

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China