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The Effect of Repetitive Transcranial Magnetic Stimulation for Poststroke Dysphagia Recovery

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ClinicalTrials.gov Identifier: NCT02090231
Recruitment Status : Unknown
Verified March 2014 by vghtpe user, Taipei Veterans General Hospital, Taiwan.
Recruitment status was:  Recruiting
First Posted : March 18, 2014
Last Update Posted : March 18, 2014
Sponsor:
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital, Taiwan

Brief Summary:
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 or disease Intervention/treatment Phase
Stroke Dysphagia Device: rTMS, Magstim Rapid2 Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Study of rTMS on Poststroke Dysphagia
Study Start Date : December 2011
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Dysphagia severity on Aus TOMs swallowing score [ Time Frame: up to 3 months ]

Secondary Outcome Measures :
  1. Imaging evidence with video-esophagography [ Time Frame: up to 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Poststroke dysphagia more than 3 months

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090231


Locations
Taiwan
Taipei Veteran General Hospital Recruiting
Taipei, Taiwan, 11217
Contact: Tsui-Fen Yang, MD    886-228757360    tfyang@vghtpe.gov.tw   
Contact: Po-Yi Tsai, MD    886-228757293    pytsai@vghtpe.gov.tw   
Principal Investigator: Po-Yi Tsai, MD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
Principal Investigator: Tsui-Fen Yang, MD No. 201, Shih- Pai Rd, Sec. 2, Taipei, 11217 Taiwan.

Responsible Party: vghtpe user, Po-Yi Tsai, MD, Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT02090231     History of Changes
Other Study ID Numbers: 2011-10-022OB
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: March 2014

Keywords provided by vghtpe user, Taipei Veterans General Hospital, Taiwan:
stroke
dysphagia
rTMS

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases