rTMS in Aphasic Patients With Neuroimage Assessments

January 5, 2021 updated by: vghtpe user, Taipei Veterans General Hospital, Taiwan

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
repetitive transcranial magnetic stimulation (rTMS) intervention of contralesional 1Hz-rTMS for 10 daily sessions.
Device: repetitive transcranial magnetic stimulation (rTMS)
undergo contralesional 1Hz repetitive transcranial magnetic stimulation(rTMS) or high frequency ipsilesional rTMS for 10 daily sessions
Sham Comparator: Sham stimulation
Sham treatment for 2-week inhibitory non-dominate hemisphere rTMS program.
Device: Sham stimulation
2-week inhibitory non-dominate hemisphere rTMS program
Experimental: High frequency rTMS
High-frequency rTMS to ipsilesional region for 10 daily sessions.
Device: repetitive transcranial magnetic stimulation (rTMS)
undergo contralesional 1Hz repetitive transcranial magnetic stimulation(rTMS) or high frequency ipsilesional rTMS for 10 daily sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in aphasia level on the Concise Chinese Aphasia Test (CCAT) at 2 Weeks
Time Frame: Up to 12 weeks
linguistic function assessment
Up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in the concomitant nervous status on the Functional magnetic resonance imaging (fMRI) at 2 weeks
Time Frame: Up to 12 weeks
brain activity change in fMRI
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Investigators

  • Principal Investigator: Po-Yi Tsai, MD, Department of physical medicine and rehabilitation, Taipei Veterans General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2017

Primary Completion (Anticipated)

December 23, 2021

Study Completion (Anticipated)

December 23, 2021

Study Registration Dates

First Submitted

January 16, 2017

First Submitted That Met QC Criteria

February 16, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

January 8, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-05-003A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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