rTMS in Aphasic Patients With Neuroimage Assessments

Stroke Clinical Trial

Official title:

Synchronous rTMS and Computer-integrated Speech Training Applied in Aphasic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03059225
• Other study ID #: 2014-05-003A
• Status: Recruiting
• Phase: N/A
• Start date: February 18, 2017
• Est. completion date: December 23, 2021

Study information

• Verified date: January 2021
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Po-Yi Tsai, MD
• Phone: 886-228757293
• Email: pytsai[@]vghtpe.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 23, 2021
• Est. primary completion date: December 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Stroke

Intervention

Device:
• repetitive transcranial magnetic stimulation (rTMS)
undergo contralesional 1Hz repetitive transcranial magnetic stimulation(rTMS) or high frequency ipsilesional rTMS for 10 daily sessions
• Sham stimulation
2-week inhibitory non-dominate hemisphere rTMS program

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Tsai PY, Wang CP, Ko JS, Chung YM, Chang YW, Wang JX. The persistent and broadly modulating effect of inhibitory rTMS in nonfluent aphasic patients: a sham-controlled, double-blind study. Neurorehabil Neural Repair. 2014 Oct;28(8):779-87. doi: 10.1177/1545968314522710. Epub 2014 Feb 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in aphasia level on the Concise Chinese Aphasia Test (CCAT) at 2 Weeks	linguistic function assessment	Up to 12 weeks
Secondary	Change from Baseline in the concomitant nervous status on the Functional magnetic resonance imaging (fMRI) at 2 weeks	brain activity change in fMRI	Up to 12 weeks