rTMS in Aphasic Patients With Neuroimage Assessments

Not Applicable

• Conditions: Stroke; Aphasia
• Interventions: Device: repetitive transcranial magnetic stimulation (rTMS); Device: Sham stimulation

• Registration Number: NCT03059225
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

The refinement of repetitive transcranial magnetic stimulation (rTMS) has highlighted its merit in terms of learning programs as a treatment for aftereffect augmentation. Nevertheless, the efficacy of synchronous rTMS protocol integrated with computer-integrated speech training is not well understood. It is also not clear regarding the efficacy of compound bi-hemispheric stimulation protocol. The aim of the study is to investigate language response to these new strategies and to determine the longevity of the therapeutic outcome. Advanced MR neuroimaging techniques, such as fMRI and DTI, are powerful tools to evaluate the concomitant nervous changes after rTMS treatment on aphasic patients. The knowledge from fMRI and DTI microstructural evolution provides insight into underlined mechanism operating the language improvement.

Detailed Description

The efficacy of synchronous rTMS protocol integrated with computer-integrated speech training is not well understood. It is also not clear regarding the efficacy of inhibitory or excitatory stimulation protocol. The aim of the study is to investigate language response to these new strategies and to determine the longevity of the therapeutic outcome. Advanced MR neuroimaging techniques, such as fMRI and DTI, are powerful tools to evaluate the concomitant nervous changes after rTMS treatment on aphasic patients. The knowledge from fMRI and DTI microstructural evolution provides insight into underlined mechanism operating the language improvement

Study Timeline

• Study First Submitted: 2017-01-16
• Study First Submitted QC: 2017-02-16
• Study Start: 2017-02-18
• Study First Posted: 2017-02-23
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-05
• Last Update Posted: 2021-01-08
• Primary Completion: 2021-12-23
• Study Completion: 2021-12-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Aphasic stroke in chronic stage (over 3 months)

Exclusion Criteria

• No seizure history, no brain surgery history, no electronic device in brain or chest, no dementia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	repetitive transcranial magnetic stimulation (rTMS)	repetitive transcranial magnetic stimulation (rTMS) intervention of contralesional 1Hz-rTMS for 10 daily sessions.
Sham stimulation	Sham stimulation	Sham treatment for 2-week inhibitory non-dominate hemisphere rTMS program.
High frequency rTMS	repetitive transcranial magnetic stimulation (rTMS)	High-frequency rTMS to ipsilesional region for 10 daily sessions.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in aphasia level on the Concise Chinese Aphasia Test (CCAT) at 2 Weeks	Up to 12 weeks	linguistic function assessment

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in the concomitant nervous status on the Functional magnetic resonance imaging (fMRI) at 2 weeks	Up to 12 weeks	brain activity change in fMRI

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan