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The Effect of Repetitive Transcranial Magnetic Stimulation for Poststroke Dysphagia Recovery

Primary Purpose

Stroke, Dysphagia

Status

Unknown status

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

rTMS, Magstim Rapid2

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, dysphagia, rTMS

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Poststroke dysphagia more than 3 months

Exclusion Criteria:

Hx of seizure or a metalic device in brain or chest

Sites / Locations

Taipei Veteran General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real 5 Hz rTMS

sham 5 Hz rTMS

Arm Description

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

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

Outcomes

Primary Outcome Measures

Dysphagia severity on Aus TOMs swallowing score

Secondary Outcome Measures

Imaging evidence with video-esophagography

Full Information

NCT ID

NCT02090231

First Posted

March 11, 2014

Last Updated

March 14, 2014

Sponsor

Taipei Veterans General Hospital, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT02090231

Brief Title

The Effect of Repetitive Transcranial Magnetic Stimulation for Poststroke Dysphagia Recovery

Official Title

Phase 2 Study of rTMS on Poststroke Dysphagia

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Unknown status

Study Start Date

December 2011 (undefined)

Primary Completion Date

July 2015 (Anticipated)

Study Completion Date

August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Taipei Veterans General Hospital, Taiwan

4. Oversight

Data Monitoring Committee

Yes

5. 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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Dysphagia

Keywords

stroke, dysphagia, rTMS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Real 5 Hz rTMS

Arm Type

Experimental

Arm Description

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

Arm Title

sham 5 Hz rTMS

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

rTMS, Magstim Rapid2

Intervention Description

5 Hz rTMS

Primary Outcome Measure Information:

Title

Dysphagia severity on Aus TOMs swallowing score

Time Frame

up to 3 months

Secondary Outcome Measure Information:

Title

Imaging evidence with video-esophagography

Time Frame

up to 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Poststroke dysphagia more than 3 months Exclusion Criteria: Hx of seizure or a metalic device in brain or chest

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tsui-Fen Yang, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Taipei Veteran General Hospital

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tsui-Fen Yang, MD

Phone

886-228757360

tfyang@vghtpe.gov.tw

First Name & Middle Initial & Last Name & Degree

Po-Yi Tsai, MD

Phone

886-228757293

pytsai@vghtpe.gov.tw

First Name & Middle Initial & Last Name & Degree

Po-Yi Tsai, MD

12. IPD Sharing Statement

Learn more about this trial

The Effect of Repetitive Transcranial Magnetic Stimulation for Poststroke Dysphagia Recovery

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