The Effect of Repetitive Transcranial Magnetic Stimulation for Poststroke Dysphagia Recovery

March 14, 2014 updated by: vghtpe user, Taipei Veterans General Hospital, Taiwan

Phase 2 Study of rTMS on Poststroke Dysphagia

Dysphagia is one of severe complications among stroke survivors. Dysphagia is usually associated with high levels of morbidity, mortality, and financial cost. In recent years, repetitive transcranial magnetic stimulation (rTMS) has shown promise to facilitate poststroke dysphagia. However, most researches were preliminary studies in the past. The present study aims to investigate the immediate and long-term efficacy of high frequency rTMS on chronic dysphagic patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

rTMS protocol: 5 Hz real or sham stimulation, 10 minutes per day, for 10 week-days.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

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 Veteran General Hospital
        • Contact:
        • Contact:

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Poststroke dysphagia more than 3 months

Exclusion Criteria:

  • Hx of seizure or a metalic device in brain or chest

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Real 5 Hz rTMS
real 5 Hz rTMS, 10 minutes per day, for 10 weekdays.
Device: rTMS, Magstim Rapid2
5 Hz rTMS
Sham Comparator: sham 5 Hz rTMS
sham 5Hz rTMS, 10 minutes per day, for 10 weekdays.
Device: rTMS, Magstim Rapid2
5 Hz rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dysphagia severity on Aus TOMs swallowing score
Time Frame: up to 3 months
up to 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Imaging evidence with video-esophagography
Time Frame: up to 3 months
up to 3 months

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: Tsui-Fen Yang, MD, No. 201, Shih- Pai Rd, Sec. 2, Taipei, 11217 Taiwan.

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

December 1, 2011

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

March 11, 2014

First Submitted That Met QC Criteria

March 14, 2014

First Posted (Estimate)

March 18, 2014

Study Record Updates

Last Update Posted (Estimate)

March 18, 2014

Last Update Submitted That Met QC Criteria

March 14, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-10-022OB

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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