StrokePhase 2NCT02090231
The Effect of Repetitive Transcranial Magnetic Stimulation for Poststroke Dysphagia Recovery
A Phase 2 study testing rTMS, Magstim Rapid2 in people with Stroke and Dysphagia, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- What is being tested?
- rTMS, Magstim Rapid2
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2011to Aug 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Poststroke dysphagia more than 3 months
Who cannot join
- Hx of seizure or a metalic device in brain or chest
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veteran General Hospital
Taipei, 11217
Tsui-Fen Yang, MD, 886-228757360, tfyang@vghtpe.gov.tw
Po-Yi Tsai, MD, 886-228757293, pytsai@vghtpe.gov.tw
About this study
Official title: Phase 2 Study of rTMS on Poststroke Dysphagia
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.
Read the detailed description
rTMS protocol: 5 Hz real or sham stimulation, 10 minutes per day, for 10 week-days.
- Being tested
- rTMS, Magstim Rapid2
- Keywords
- stroke, dysphagia, rTMS
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS, Magstim Rapid2Device
5 Hz rTMS
| Study group | Role | What they receive |
|---|---|---|
| Real 5 Hz rTMS | Experimental | real 5 Hz rTMS, 10 minutes per day, for 10 weekdays. Receives: Device: rTMS, Magstim Rapid2 |
| sham 5 Hz rTMS | Sham comparator | sham 5Hz rTMS, 10 minutes per day, for 10 weekdays. Receives: Device: rTMS, Magstim Rapid2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysphagia severity on Aus TOMs swallowing score
Measured: up to 3 months
Secondary outcomes (1)
Imaging evidence with video-esophagography
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startDec 2011
- Primary completionJul 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
- Investigators
- Tsui-Fen Yang, MD, Principal investigator, No. 201, Shih- Pai Rd, Sec. 2, Taipei, 11217 Taiwan.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090231
- Sponsor's protocol ID
- 2011-10-022OB
- Status last verified
- Mar 2014
- First submitted
- 11 Mar 2014
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of rTMS on Poststroke Dysphagia
- ClinicalTrials.gov ID
- NCT02090231
- Acronym / sponsor ID
- 2011-10-022OB
- Keywords
- stroke, dysphagia, rTMS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Dec 2011
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 18 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real 5 Hz rTMS | Experimental | Device: rTMS, Magstim Rapid2real 5 Hz rTMS, 10 minutes per day, for 10 weekdays. |
| sham 5 Hz rTMS | Sham comparator | Device: rTMS, Magstim Rapid2sham 5Hz rTMS, 10 minutes per day, for 10 weekdays. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Poststroke dysphagia more than 3 months
Key exclusion criteria (1 listed)
- Hx of seizure or a metalic device in brain or chest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMS, Magstim Rapid25 Hz rTMS | Device | Real 5 Hz rTMS, sham 5 Hz rTMS |
Primary outcome
Dysphagia severity on Aus TOMs swallowing score
Time frame: up to 3 months
1 secondary outcome
Imaging evidence with video-esophagography
Time frame: up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsui-Fen Yang, MD principal investigator
No. 201, Shih- Pai Rd, Sec. 2, Taipei, 11217 Taiwan.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rTMS, Magstim Rapid2 in people with Stroke and Dysphagia, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysphagia severity on Aus TOMs swallowing score (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2014.