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CompletedNCT02893033Updated Jun 20, 2017

Neuromodulation With rTMS in Dysphagic Patients With Stroke

An interventional study of repetitive transcranial magnetic stimulation in Transcranial Magnetic Stimulation, sponsored by Taipei Veterans General Hospital, Taiwan. Completed. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-06-20.

Sponsored by Taipei Veterans General Hospital, Taiwan · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Transcranial Magnetic Stimulation

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Keywords

  • Dysphagia
  • Repetitive Transcranial Magnetic Stimulation
  • Stroke
03

In context

Stroke

7,287 studies on the registry are indexed under Stroke; 2,006 are open to participants now.

This study's enrollment of 5 is below the median of 50 across 5,370 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Taipei Veterans General Hospital, Taiwan is the lead sponsor of 325 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. a diagnosis of stroke related dysphagia
  2. no concurrent neurodegenerative or dementia history
  3. an absence of TMS contraindications.

Exclusion criteria

Exclusion Criteria:

  • arrythmia, epilepsy, infection, hyperglycemia, pacemaker or implants, external ventricular drain or ventriculoperitoneal shunt
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    Real stimulation

    Real repetitive transcranial magnetic stimulation + swallowing training

    Device: repetitive transcranial magnetic stimulation

  • Sham comparator
    Sham stimulation

    Sham repetitive transcranial magnetic stimulation + swallowing training

    Device: repetitive transcranial magnetic stimulation

Interventions

  • Devicerepetitive transcranial magnetic stimulation

    rTMS

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What researchers measure

Primary outcomes

  1. functional outcome

    points of Australian Therapy Outcome Measures-the Swallowing scale as assessed by a clinical therapist

    Time frame: prior to treatment (baseline), on the next day after the 2 weeks treatment completion

Secondary outcomes

  1. videofluoroscopy

    points of Penetration-Aspiration Scale as assessed by videofluoroscopy

    Time frame: prior to treatment (baseline), on the next day after the 2 weeks treatment completion

  2. cricopharyngeal motor evoked potentials

    amplitude and latency measured by cricopharyngeal motor evoked potentials

    Time frame: prior to treatment (baseline), on the next day after the 2 weeks treatment completion

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Study locations

No study locations are listed for this record.

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References and documents

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 23480388 ↗
  • Park 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 23279198 ↗
  • Lin 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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02893033
Lead sponsor
Taipei Veterans General Hospital, Taiwan
Responsible party
Sponsor
First posted
Sep 8, 2016
Start date
Aug 2014
Primary completion
Aug 2015
Completion
Aug 2015
Last update
Jun 20, 2017

Study contacts

Po-Yi Tsai
study director · Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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