NCT02090231

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2 stroke

Timeline
Completed

Started Dec 2011

Typical duration for phase_2 stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

3.6 years

First QC Date

March 11, 2014

Last Update Submit

March 14, 2014

Conditions

StrokeDysphagia

Keywords

strokedysphagiarTMS

Outcome Measures

Primary Outcomes (1)

  • Dysphagia severity on Aus TOMs swallowing score

    up to 3 months

Secondary Outcomes (1)

  • Imaging evidence with video-esophagography

    up to 3 months

Study Arms (2)

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

rTMS, Magstim Rapid2DEVICE

5 Hz rTMS

Real 5 Hz rTMSsham 5 Hz rTMS

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Poststroke dysphagia more than 3 months

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veteran General Hospital

Taipei, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

StrokeDeglutition Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Tsui-Fen Yang, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Po-Yi Tsai, MD

Study Record Dates

First Submitted

March 11, 2014

First Posted

March 18, 2014

Study Start

December 1, 2011

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations

TW(1)