Trial record 8 of 222 for:    Open Studies | "Deglutition Disorders"

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
Sponsor:
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT02090231
First received: March 11, 2014
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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
Stroke
Dysphagia
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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

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
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:
stroke
dysphagia
rTMS

Additional relevant MeSH terms:
Deglutition Disorders
Stroke
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014