The Effect of Repetitive Transcranial Magnetic Stimulation for Poststroke Dysphagia Recovery

Phase 2

• Conditions: Stroke; Dysphagia
• Interventions: Device: rTMS, Magstim Rapid2

• Registration Number: NCT02090231
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study Start: 2011-12
• Status Verified: 2014-03
• Study First Submitted: 2014-03-11
• Study First Submitted QC: 2014-03-14
• Last Update Submitted: 2014-03-14
• Study First Posted: 2014-03-18
• Last Update Posted: 2014-03-18
• Primary Completion: 2015-07
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Poststroke dysphagia more than 3 months

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real 5 Hz rTMS	rTMS, Magstim Rapid2	real 5 Hz rTMS, 10 minutes per day, for 10 weekdays.
sham 5 Hz rTMS	rTMS, Magstim Rapid2	sham 5Hz rTMS, 10 minutes per day, for 10 weekdays.

Primary Outcome Measures

Name	Time	Method
Dysphagia severity on Aus TOMs swallowing score	up to 3 months

Secondary Outcome Measures

Name	Time	Method
Imaging evidence with video-esophagography	up to 3 months

Trial Locations

Locations (1)

Taipei Veteran General Hospital; 🇨🇳 Taipei, Taiwan