Transcranial Magnetic StimulationNCT02893033
Neuromodulation With rTMS in Dysphagic Patients With Stroke
A study testing repetitive transcranial magnetic stimulation in people with Transcranial Magnetic Stimulation, run by Taipei Veterans General Hospital, Taiwan.
Trial summary
The patients with chronic dysphagia secondary to first-ever stroke were randomly assigned to 2 groups: Group A: sham stimulation for 10 minutes , Group B: real rTMS for 10 minutes. rTMS conditioning: daily rTMS 10 min for 10 days. Assessments: 1. videofluoroscopy，2.Functional outcome swallowing scale (3 scales). 3. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Transcranial Magnetic Stimulation
- What is being tested?
- repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Aug 2015
- Phase
- Interventional
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a diagnosis of stroke related dysphagia
- no concurrent neurodegenerative or dementia history
- an absence of TMS contraindications.
Who cannot join
- arrythmia, epilepsy, infection, hyperglycemia, pacemaker or implants, external ventricular drain or ventriculoperitoneal shunt
About this study
The patients with chronic dysphagia secondary to first-ever stroke were randomly assigned to 2 groups: Group A: sham stimulation for 10 minutes , Group B: real rTMS for 10 minutes. rTMS conditioning: daily rTMS 10 min for 10 days. Assessments: 1. videofluoroscopy，2.Functional outcome swallowing scale (3 scales). 3. MEP measurements
Read the detailed description
While the reflex component of swallowing depends on swallowing centres in the brainstem, initiation of swallowing is a voluntary action that involves the integrity of motor areas of the cerebral cortex. Oropharyngeal dysphagia occurs in more than 50% of stroke patients. Aspiration pneumonia occurs in up to 20% of acute stroke patients and is a major cause of mortality after discharge. Oropharyngeal dysphagia is both underestimated and underdiagnosed as a cause of major nutritional and respiratory complications in stroke patients. Recently, transcranial magnetic stimulation (TMS) has been used to study the cortical input to swallowing control and has revealed that the topographic representation of esophageal motor function in the human cerebral cortex is bilateral but with consistent interhemispheric asymmetry unrelated to handedness.
In a number of recent studies, poststroke motor and dysphagia performance has been improved after daily treatment sessions with repetitive TMS (rTMS) using an excitatory frequency in patients with hemispheric ischaemic stroke due to occlusion of territories of the middle cerebral artery. Our hypothesis was that rTMS would facilitate dysphagia recovery.
- Conditions
- Transcranial Magnetic Stimulation
- Being tested
- repetitive transcranial magnetic stimulation
- Keywords
- Dysphagia, Repetitive Transcranial Magnetic Stimulation, Stroke
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulationDevice
rTMS
| Study group | Role | What they receive |
|---|---|---|
| Real stimulation | Experimental | Real repetitive transcranial magnetic stimulation + swallowing training Receives: Device: repetitive transcranial magnetic stimulation |
| Sham stimulation | Sham comparator | Sham repetitive transcranial magnetic stimulation + swallowing training Receives: Device: repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional outcome
points of Australian Therapy Outcome Measures-the Swallowing scale as assessed by a clinical therapist
Measured: prior to treatment (baseline), on the next day after the 2 weeks treatment completion
Secondary outcomes (2)
videofluoroscopy
points of Penetration-Aspiration Scale as assessed by videofluoroscopy
Measured: prior to treatment (baseline), on the next day after the 2 weeks treatment completion
cricopharyngeal motor evoked potentials
amplitude and latency measured by cricopharyngeal motor evoked potentials
Measured: prior to treatment (baseline), on the next day after the 2 weeks treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startAug 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Transcranial Magnetic StimulationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Po-Yi Tsai, Study director, Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893033
- Sponsor's protocol ID
- 2014-07-007C
- Status last verified
- Jul 2016
- First submitted
- 26 Aug 2016
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rofes L, Vilardell N, Clave P. Post-stroke dysphagia: progress at last. Neurogastroenterol Motil. 2013 Apr;25(4):278-82. doi: 10.1111/nmo.12112. Epub 2013 Mar 11.
PubMed 23480388Park JW, Oh JC, Lee JW, Yeo JS, Ryu KH. The effect of 5Hz high-frequency rTMS over contralesional pharyngeal motor cortex in post-stroke oropharyngeal dysphagia: a randomized controlled study. Neurogastroenterol Motil. 2013 Apr;25(4):324-e250. doi: 10.1111/nmo.12063. Epub 2012 Dec 23.
PubMed 23279198Lin WS, Chou CL, Chang MH, Chung YM, Lin FG, Tsai PY. Vagus nerve magnetic modulation facilitates dysphagia recovery in patients with stroke involving the brainstem - A proof of concept study. Brain Stimul. 2018 Mar-Apr;11(2):264-270. doi: 10.1016/j.brs.2017.10.021. Epub 2017 Nov 7.
PubMed 29162502
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation With rTMS in Dysphagic Patients With Stroke
- ClinicalTrials.gov ID
- NCT02893033
- Acronym / sponsor ID
- 2014-07-007C
- Conditions
- Transcranial Magnetic Stimulation
- Keywords
- Dysphagia, Repetitive Transcranial Magnetic Stimulation, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Aug 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 8 Sep 2016 (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.
The patients with chronic dysphagia secondary to first-ever stroke were randomly assigned to 2 groups: Group A: sham stimulation for 10 minutes , Group B: real rTMS for 10 minutes. rTMS conditioning: daily rTMS 10 min for 10 days. Assessments: 1. videofluoroscopy，2.Functional outcome swallowing scale (3 scales). 3. MEP measurements
Detailed description
While the reflex component of swallowing depends on swallowing centres in the brainstem, initiation of swallowing is a voluntary action that involves the integrity of motor areas of the cerebral cortex. Oropharyngeal dysphagia occurs in more than 50% of stroke patients. Aspiration pneumonia occurs in up to 20% of acute stroke patients and is a major cause of mortality after discharge. Oropharyngeal dysphagia is both underestimated and underdiagnosed as a cause of major nutritional and respiratory complications in stroke patients. Recently, transcranial magnetic stimulation (TMS) has been used to study the cortical input to swallowing control and has revealed that the topographic representation of esophageal motor function in the human cerebral cortex is bilateral but with consistent interhemispheric asymmetry unrelated to handedness.
In a number of recent studies, poststroke motor and dysphagia performance has been improved after daily treatment sessions with repetitive TMS (rTMS) using an excitatory frequency in patients with hemispheric ischaemic stroke due to occlusion of territories of the middle cerebral artery. Our hypothesis was that rTMS would facilitate dysphagia recovery.
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 stimulation | Experimental | Device: repetitive transcranial magnetic stimulationReal repetitive transcranial magnetic stimulation + swallowing training |
| Sham stimulation | Sham comparator | Device: repetitive transcranial magnetic stimulationSham repetitive transcranial magnetic stimulation + swallowing training |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a diagnosis of stroke related dysphagia
- no concurrent neurodegenerative or dementia history
- an absence of TMS contraindications.
Key exclusion criteria (1 listed)
- arrythmia, epilepsy, infection, hyperglycemia, pacemaker or implants, external ventricular drain or ventriculoperitoneal shunt
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 |
|---|---|---|
| repetitive transcranial magnetic stimulationrTMS | Device | Real stimulation, Sham stimulation |
Primary outcome
functional outcome
Time frame: prior to treatment (baseline), on the next day after the 2 weeks treatment completion
points of Australian Therapy Outcome Measures-the Swallowing scale as assessed by a clinical therapist
2 secondary outcomes
videofluoroscopy
Time frame: prior to treatment (baseline), on the next day after the 2 weeks treatment completion
cricopharyngeal motor evoked potentials
Time frame: prior to treatment (baseline), on the next day after the 2 weeks treatment completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Background: PubMed 23480388Rofes L, Vilardell N, Clave P. Post-stroke dysphagia: progress at last. Neurogastroenterol Motil. 2013 Apr;25(4):278-82. doi: 10.1111/nmo.12112. Epub 2013 Mar 11.
- Background: PubMed 23279198Park JW, Oh JC, Lee JW, Yeo JS, Ryu KH. The effect of 5Hz high-frequency rTMS over contralesional pharyngeal motor cortex in post-stroke oropharyngeal dysphagia: a randomized controlled study. Neurogastroenterol Motil. 2013 Apr;25(4):324-e250. doi: 10.1111/nmo.12063. Epub 2012 Dec 23.
- Derived from this study: PubMed 29162502Lin WS, Chou CL, Chang MH, Chung YM, Lin FG, Tsai PY. Vagus nerve magnetic modulation facilitates dysphagia recovery in patients with stroke involving the brainstem - A proof of concept study. Brain Stimul. 2018 Mar-Apr;11(2):264-270. doi: 10.1016/j.brs.2017.10.021. Epub 2017 Nov 7.
- Individual participant dataSharing planned: No
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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.
Po-Yi Tsai study director
Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan
Questions about this trial
What is this clinical trial studying?
A study testing repetitive transcranial magnetic stimulation in people with Transcranial Magnetic Stimulation, run by Taipei Veterans General Hospital, 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 3 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: finished, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional outcome (time frame: prior to treatment (baseline), on the next day after the 2 weeks treatment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02893033, which also lists 3 linked publications.
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 20 Jun 2017.