The Effect of Repetitive Transcranial Magnetic Stimulation for Poststroke Dysphagia Recovery

NCT ID: NCT02090231

Last Updated: 2014-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-08-31

Brief Summary

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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

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

Conditions

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Stroke Dysphagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Real 5 Hz rTMS

real 5 Hz rTMS, 10 minutes per day, for 10 weekdays.

Group Type EXPERIMENTAL

rTMS, Magstim Rapid2

Intervention Type DEVICE

5 Hz rTMS

sham 5 Hz rTMS

sham 5Hz rTMS, 10 minutes per day, for 10 weekdays.

Group Type SHAM_COMPARATOR

rTMS, Magstim Rapid2

Intervention Type DEVICE

5 Hz rTMS

Interventions

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rTMS, Magstim Rapid2

5 Hz rTMS

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Poststroke dysphagia more than 3 months

Exclusion Criteria

* Hx of seizure or a metalic device in brain or chest
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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vghtpe user

Po-Yi Tsai, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tsui-Fen Yang, MD

Role: PRINCIPAL_INVESTIGATOR

No. 201, Shih- Pai Rd, Sec. 2, Taipei, 11217 Taiwan.

Locations

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Taipei Veteran General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Facility Contacts

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Tsui-Fen Yang, MD

Role: primary

886-228757360

Po-Yi Tsai, MD

Role: backup

886-228757293

Other Identifiers

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2011-10-022OB

Identifier Type: -

Identifier Source: org_study_id

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