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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
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transcranial Magnetic Stimulation focused on measuring Dysphagia, Repetitive Transcranial Magnetic Stimulation, Stroke

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

    First Posted
    August 26, 2016
    Last Updated
    June 19, 2017
    Sponsor
    Taipei Veterans General Hospital, Taiwan
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    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

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    Neuromodulation With rTMS in Dysphagic Patients With Stroke

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