- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02893033
Neuromodulation With rTMS in Dysphagic Patients With Stroke
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- a diagnosis of stroke related dysphagia
- no concurrent neurodegenerative or dementia history
- an absence of TMS contraindications.
Exclusion Criteria:
- arrythmia, epilepsy, infection, hyperglycemia, pacemaker or implants, external ventricular drain or ventriculoperitoneal shunt
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Real stimulation
Real repetitive transcranial magnetic stimulation + swallowing training
|
rTMS
|
Sham Comparator: Sham stimulation
Sham repetitive transcranial magnetic stimulation + swallowing training
|
rTMS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
prior to treatment (baseline), on the next day after the 2 weeks treatment completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
videofluoroscopy
Time Frame: prior to treatment (baseline), on the next day after the 2 weeks treatment completion
|
points of Penetration-Aspiration Scale as assessed by videofluoroscopy
|
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
|
amplitude and latency measured by cricopharyngeal motor evoked potentials
|
prior to treatment (baseline), on the next day after the 2 weeks treatment completion
|
Collaborators and Investigators
Investigators
- Study Director: Po-Yi Tsai, Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-07-007C
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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