The Effect of Repetitive Transcranial Magnetic Stimulation for Poststroke Dysphagia Recovery

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Taipei Veterans General Hospital, Taiwan
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital, Taiwan Identifier:
First received: March 11, 2014
Last updated: March 14, 2014
Last verified: March 2014
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.

Condition Intervention Phase
Device: rTMS, Magstim Rapid2
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Study of rTMS on Poststroke Dysphagia

Resource links provided by NLM:

Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • Dysphagia severity on Aus TOMs swallowing score [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Imaging evidence with video-esophagography [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Poststroke dysphagia more than 3 months

Exclusion Criteria:

  • Hx of seizure or a metalic device in brain or chest
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02090231

Taipei Veteran General Hospital Recruiting
Taipei, Taiwan, 11217
Contact: Tsui-Fen Yang, MD    886-228757360   
Contact: Po-Yi Tsai, MD    886-228757293   
Principal Investigator: Po-Yi Tsai, MD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Principal Investigator: Tsui-Fen Yang, MD No. 201, Shih- Pai Rd, Sec. 2, Taipei, 11217 Taiwan.
  More Information

No publications provided

Responsible Party: vghtpe user, Po-Yi Tsai, MD, Taipei Veterans General Hospital, Taiwan Identifier: NCT02090231     History of Changes
Other Study ID Numbers: 2011-10-022OB 
Study First Received: March 11, 2014
Last Updated: March 14, 2014
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by Taipei Veterans General Hospital, Taiwan:

Additional relevant MeSH terms:
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Otorhinolaryngologic Diseases
Pharyngeal Diseases processed this record on February 09, 2016