The Effect of Repetitive Transcranial Magnetic Stimulatio... | NCT02090231

Studies
The Effect of Repetitive Transcranial Magnetic Stimulation for Poststroke Dysphagia Recovery

NCT02090231

Sponsor

Taipei Veterans General Hospital, Taiwan

Status

Unknown status

Last Update Posted

Mar 18, 2014Estimated

Enrollment

50Estimated

Phase

Phase 2

Conditions

Stroke
Dysphagia

Interventions

rTMS, Magstim Rapid2

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Jul 2015Estimated

Completion Date

Aug 2015Estimated

First Submitted Date

Mar 11, 2014

First Submission Date that Met QC Criteria

Mar 14, 2014

First Posted Date

Mar 18, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2014

Last Update Posted Date

Mar 18, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

vghtpe user, Po-Yi Tsai, MD, Taipei Veterans General Hospital, TaiwanPrincipal Investigator

Lead Sponsor

Taipei Veterans General Hospital, TaiwanOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Real 5 Hz rTMS	Experimental	real 5 Hz rTMS, 10 minutes per day, for 10 weekdays.	Device: rTMS, Magstim Rapid2
sham 5 Hz rTMS	Sham Comparator	sham 5Hz rTMS, 10 minutes per day, for 10 weekdays.	Device: rTMS, Magstim Rapid2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rTMS, Magstim Rapid2	Device	5 Hz rTMS	Real 5 Hz rTMS sham 5 Hz rTMS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dysphagia severity on Aus TOMs swallowing score		up to 3 months

Secondary Outcomes

Measure	Description	Time Frame
Imaging evidence with video-esophagography		up to 3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Poststroke dysphagia more than 3 months

Exclusion Criteria:

Hx of seizure or a metalic device in brain or chest

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tsui-Fen Yang, MD	No. 201, Shih- Pai Rd, Sec. 2, Taipei, 11217 Taiwan.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taipei Veteran General Hospital	Recruiting	Taipei		11217	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D003680	Deglutition Disorders

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D050781	Transcranial Magnetic Stimulation

Ancestor Terms

ID	Term
D055909	Magnetic Field Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided