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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02090231
Other study ID # 2011-10-022OB
Secondary ID
Status Recruiting
Phase Phase 2
First received March 11, 2014
Last updated March 14, 2014
Start date December 2011
Est. completion date August 2015

Study information

Verified date March 2014
Source Taipei Veterans General Hospital, Taiwan
Contact n/a
Is FDA regulated No
Health authority Taiwan : Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date August 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 70 Years
Eligibility Inclusion Criteria:

- Poststroke dysphagia more than 3 months

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
rTMS, Magstim Rapid2
5 Hz rTMS

Locations

Country Name City State
Taiwan Taipei Veteran General Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dysphagia severity on Aus TOMs swallowing score up to 3 months No
Secondary Imaging evidence with video-esophagography up to 3 months No
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