Functional Neuroimage in Assessment of Post-stroke Aphasia

April 18, 2014 updated by: vghtpe user

Phase 2 Study of rTMS Application in Aphasic Patients Evaluated With fMRI

The substantial efficacy and the possible mechanism of repetitive transcranial magnetic stimulation (rTMS) improving language recovery remained unclear. It is hypothesized that the rTMS was associated with increased synaptic connection and neural regeneration which can be evaluated via functional neuroimage and neurofiber imaging analysis. The effect of rTMS intervention was monitored by clinical testing and neuroimaging study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

2-week rTMS modulation has been proved to produce substantial clinical benefit with sham-controlled study. This trial aimed to investigate the possible mechanism and make clinical correlation.

Study Type

Interventional

Enrollment (Anticipated)

60

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, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
          • Po-Yi Tsai, MD
          • Phone Number: 886-228757293

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

25 years to 80 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: 1 Hz rTMS, real
1 Hz rTMS over unaffected hemisphere for 15 minutes
Device: rTMS
To test the efficacy of this specific setting.
Other Names:
  • Magstim, Rapid2
Sham Comparator: 1Hz rTMS, sham
1Hz sham rTMS, over unaffected hemisphere for 15 minutes
Device: rTMS
To test the efficacy of this specific setting.
Other Names:
  • Magstim, Rapid2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concise Chinese Aphasia Test
Time Frame: Before the rTMS intervention, at 2nd week, and 3rd month
Assess the linguistic skills such as conversation, expression, description, comprehension...
Before the rTMS intervention, at 2nd week, and 3rd month

Secondary Outcome Measures

Outcome Measure
Time Frame
Functional MRI
Time Frame: Before rTMS intervention, and at the day completing the rTMS treatment.
Before rTMS intervention, and at the day completing the rTMS treatment.

Collaborators and Investigators

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

Sponsor

vghtpe user

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

August 1, 2012

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

April 18, 2014

First Submitted That Met QC Criteria

April 18, 2014

First Posted (Estimate)

April 22, 2014

Study Record Updates

Last Update Posted (Estimate)

April 22, 2014

Last Update Submitted That Met QC Criteria

April 18, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201207007AC

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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