Neuromodulation With rTMS in Dysphagic Patients With Stroke
Primary Purpose
Transcranial Magnetic Stimulation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
repetitive transcranial magnetic stimulation
Sponsored by

About this trial
This is an interventional treatment trial for Transcranial Magnetic Stimulation focused on measuring Dysphagia, Repetitive Transcranial Magnetic Stimulation, Stroke
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Real stimulation
Sham stimulation
Arm Description
Real repetitive transcranial magnetic stimulation + swallowing training
Sham repetitive transcranial magnetic stimulation + swallowing training
Outcomes
Primary Outcome Measures
functional outcome
points of Australian Therapy Outcome Measures-the Swallowing scale as assessed by a clinical therapist
Secondary Outcome Measures
videofluoroscopy
points of Penetration-Aspiration Scale as assessed by videofluoroscopy
cricopharyngeal motor evoked potentials
amplitude and latency measured by cricopharyngeal motor evoked potentials
Full Information
NCT ID
NCT02893033
First Posted
August 26, 2016
Last Updated
June 19, 2017
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT02893033
Brief Title
Neuromodulation With rTMS in Dysphagic Patients With Stroke
Official Title
Neuromodulation With rTMS in Dysphagic Patients With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transcranial Magnetic Stimulation
Keywords
Dysphagia, Repetitive Transcranial Magnetic Stimulation, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Real stimulation
Arm Type
Experimental
Arm Description
Real repetitive transcranial magnetic stimulation + swallowing training
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
Sham repetitive transcranial magnetic stimulation + swallowing training
Intervention Type
Device
Intervention Name(s)
repetitive transcranial magnetic stimulation
Intervention Description
rTMS
Primary Outcome Measure Information:
Title
functional outcome
Description
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 Outcome Measure Information:
Title
videofluoroscopy
Description
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
Title
cricopharyngeal motor evoked potentials
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Po-Yi Tsai
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23480388
Citation
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.
Results Reference
background
PubMed Identifier
23279198
Citation
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.
Results Reference
background
PubMed Identifier
29162502
Citation
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.
Results Reference
derived
Learn more about this trial
Neuromodulation With rTMS in Dysphagic Patients With Stroke
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