The Effect of Repetitive Transcranial Magnetic Stimulation for Poststroke Dysphagia Recovery

• Sponsor: Taipei Veterans General Hospital, Taiwan (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02090231
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 44
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Dec 1, 2011
• Anticipated Primary Completion Date: Jul 1, 2015
• Anticipated Study Completion Date: Aug 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Dysphagia severity on Aus TOMs swallowing score [up to 3 months]

Secondary Outcome Measures

1. Imaging evidence with video-esophagography [up to 3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 70 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Taipei Veteran General Hospital	Taipei		Taiwan	11217

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.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: vghtpe user, Po-Yi Tsai, MD, Taipei Veterans General Hospital, Taiwan
• ClinicalTrials.gov Identifier: NCT02090231
• Other Study ID Numbers: 2011-10-022OB
• First Posted: Mar 18, 2014
• Last Update Posted: Mar 18, 2014
• Last Verified: Mar 1, 2014

• Keywords provided by vghtpe user, Po-Yi Tsai, MD, Taipei Veterans General Hospital, Taiwan: stroke; dysphagia; rTMS
• Additional relevant MeSH terms: Deglutition Disorders

Study Results

No Results Posted as of Mar 18, 2014