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rTMS in Chronic Poststroke Dysphagia

Primary Purpose

Deglutition Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
repetitive transcranial magnetic stimulation(rTMS)
Intermittent Theta-burst Stimulation(iTBS)
Sham stimulation
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age > 20 years old, diagnosed of subcortical stroke(including ischemic or hemorrhagic type) by CT or MRI image study
  • sustained the symptoms of dysphagia more than one month after stroke.
  • Functional Oral Intake Scale (FOIS) between 1 to 5 score
  • Maintenance on sitting balance over 15 minutes

Exclusion Criteria:

  • Disturbed consciousness, unable to communicate and obey order through gesture or language
  • Disease or trauma involved central neural system, such as Parkinson's disease, traumatic brain injury, brain tumor or multiple sclerosis
  • Any disorder inducing dysphagia, such as nasopharyngeal cancer(NPC) or cervical cancer
  • Metal Implants or pacemaker
  • Global aphasia or cognitive impairment
  • History of epilepsy
  • Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    bilateral rTMS

    unilateral rTMS

    control group of rTMS

    bilateral iTBS

    unilateral iTBS

    control group of iTBS

    Arm Description

    5 hertz(Hz), 1000 pulses, 90% resting motor threshold(RMT) stimulation on bilateral motor cortex of suprahyoid muscle for 15 minutes.

    5 hertz(Hz), 1000 pulses, 90% RMT stimulation on motor cortex of suprahyoid muscle at ipsilateral side as the lesion for 15 minutes; sham stimulation on motor cortex of suprahyoid muscle at contra-lateral side as the lesion for 15 minutes.

    Sham stimulation on motor cortex of suprahyoid muscle at contra-lateral side as the lesion for 15 minutes.

    600 pulses iTBS stimulation on bilateral motor cortex of suprahyoid muscle for 15 minutes.

    600 pulses iTBS on motor cortex of suprahyoid muscle at ipsilateral side as the lesion for 15 minutes; sham stimulation on motor cortex of suprahyoid muscle at contra-lateral side as the lesion for 15 minutes.

    Sham stimulation on motor cortex of suprahyoid muscle at contra-lateral side as the lesion for 15 minutes.

    Outcomes

    Primary Outcome Measures

    penetration-aspiration scale(PAS)
    Penetration-aspiration scale will be calculated by videofluoroscopic swallow study with measurement of the depth of penetrated or aspirated material and the patient's response to airway invasion. Score range is 1 to 8; higher score means more severe on penetration and aspiration.
    penetration-aspiration scale(PAS)
    Penetration-aspiration scale will be calculated by videofluoroscopic swallow study with measurement of the depth of penetrated or aspirated material and the patient's response to airway invasion. Score range is 1 to 8; higher score means more severe on penetration and aspiration.

    Secondary Outcome Measures

    The Swallowing Quality-of-Life questionnaire(SWAL-QOL)
    The questionnaire to assess ten quality-of-life concepts about dysphagia, containing 44-items and dividing into 10 domains. The score of each item ranges from 0 to 4 and total score ranges from 0 to 100. Higher score means better swallow-specific quality of life.
    The Functional Oral Intake Scale (FOIS)
    Measurement of functional level of oral intake of food and liquid with 7-point ordinal scale, level 1 to level 7. Higher level means better performance and lower limitation on oral intake.
    The Dysphagia Severity Scale (DSS)
    Combination of objective evaluation of the functional severity of dysphagia and recommendations for diet level. Level range is from 1 to 7; lower level means more severe on dysphagia and aspiration.
    Iowa Oral Performance Instrument (IOPI)
    Objectively evaluate and measure tongue and lip strength and endurance
    Swallowing ultrasound
    The ultrasound of swallowing to evaluate the movement of hyoid bone
    Motor evoked potential (MEP)
    Record the MEP of suprahyoid muscle under rTMS

    Full Information

    First Posted
    October 6, 2022
    Last Updated
    February 1, 2023
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05590819
    Brief Title
    rTMS in Chronic Poststroke Dysphagia
    Official Title
    The Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Poststroke Dysphagia.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 5, 2023 (Anticipated)
    Primary Completion Date
    May 1, 2024 (Anticipated)
    Study Completion Date
    August 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this study is to investigate the therapeutic efficacy of repetitive transcranial magnetic stimulation (rTMS) and intermittent theta burst stimulation (iTBS) applying on suprahyoid motor cortex in chronic poststroke dysphagia, and its effect on hyolaryngeal movement. Participants will be randomized into three groups. The three experimental groups received either bilateral or ipsilateral rTMS, or iTBS (with contralateral sham stimulation) at suprahyoid motor cortex, while the placebo group received bilateral sham stimulation. Stimulation will be given at 5 hertz(Hz), 1000 pulses of rTMS or 600 pulses of iTBS per session, for a total of 10 sessions. The swallowing function, penetration-aspiration scale of video-fluoroscopic swallowing study, motor evoked potential of suprahyoid muscles, intraoral pressure, and ultrasound swallowing exam will be evaluated before therapy, and at 1, 3, 6 months post therapy.
    Detailed Description
    Swallowing dysfunction, or dysphagia, is a common complication following stroke. Although spontaneous recovery of swallowing function was seen in most patients in a time course of a few weeks to 6 months after stroke, around 50% of patients recovered slowly and had chronic dysphagia clinically. It is worth noting that dysphagia has great impact on clinical outcome, in terms of not only quality of life but also risk of severe complication such as aspiration pneumonia, malnutrition, and even death. After damage on swallowing ability, several cause would arise risk of aspiration and one of them was inadequate hyolaryngeal elevation. Suprahyoid muscle played an important role in hyolaryngeal movement so re-training on suprahyoid muscle might be an efficient method. Conventional treatments of dysphagia focused on restore or improve swallowing functions through oropharyngeal muscle training, swallowing maneuvers, or compensation strategy. However, the effectiveness of traditional therapy was still limited and inconsistent. Noninvasive brain stimulation (NIBS) has gained increasing attention as a promising neuromodulation therapy which could improve neurological deficit and functional level through inducing the cortical neuroplasticity. Among NIBS, repetitive transcranial magnetic stimulation (rTMS) is the most widely used and delved. It has been utilized in stroke patient for promoting functional reorganization and modulate neural connection in motor and language area. In a previous network meta-analysis, we also indicated that rTMS showed the best efficacy in improving the swallowing function in acute and subacute poststroke dysphagia, when compared with transcranial direct current stimulation, surface neuromuscular electrical stimulation, and pharyngeal electrical stimulation (PES). Despite of the positive results, there was still limited evidence on the effect of rTMS in chronic dysphagia and the mechanism by which rTMS improved dysphagia outcome is unclear. Specifically, whether the rTMS on a representation cortex directly increase functional gain, such as strength and contractility of the target area remained unclear. On the other hand, theta burst stimulation (TBS), consisting of continuous TBS (cTBS) and intermittent TBS (iTBS), is a new stimulation model of TMS and seemed to be helpful on motor recovery in chronic stroke. Furthermore, previous research had showed iTBS was not inferior to rTMS on the improvement of poststroke dysphagia using stimulation at suprahyoid motor cortex of affected hemisphere. In this study, we aim to investigate the therapeutic efficacy of both high frequency rTMS and iTBS applying on suprahyoid motor cortex in chronic poststroke dysphagia, and its effect on hyolaryngeal movement. In each stage, patients with subcortical stroke will be randomized into three groups. The three experimental groups receive either bilateral or ipsilateral rTMS, or iTBS (with contralateral sham stimulation) at suprahyoid motor cortex, while the placebo group receive bilateral sham stimulation. Stimulation will be given at 5 hertz(Hz), 1000 pulses of rTMS or 600 pulses of iTBS per session, for a total of 10 sessions. The swallowing function, penetration-aspiration scale of video-fluoroscopic swallowing study, motor evoked potential of suprahyoid muscles, intraoral pressure, and ultrasound swallowing exam will be evaluated before therapy, and at 1, 3, 6 months post therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Deglutition Disorders
    Keywords
    Transcranial Magnetic Stimulation, Dysphagia, Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    bilateral rTMS
    Arm Type
    Experimental
    Arm Description
    5 hertz(Hz), 1000 pulses, 90% resting motor threshold(RMT) stimulation on bilateral motor cortex of suprahyoid muscle for 15 minutes.
    Arm Title
    unilateral rTMS
    Arm Type
    Experimental
    Arm Description
    5 hertz(Hz), 1000 pulses, 90% RMT stimulation on motor cortex of suprahyoid muscle at ipsilateral side as the lesion for 15 minutes; sham stimulation on motor cortex of suprahyoid muscle at contra-lateral side as the lesion for 15 minutes.
    Arm Title
    control group of rTMS
    Arm Type
    Placebo Comparator
    Arm Description
    Sham stimulation on motor cortex of suprahyoid muscle at contra-lateral side as the lesion for 15 minutes.
    Arm Title
    bilateral iTBS
    Arm Type
    Experimental
    Arm Description
    600 pulses iTBS stimulation on bilateral motor cortex of suprahyoid muscle for 15 minutes.
    Arm Title
    unilateral iTBS
    Arm Type
    Experimental
    Arm Description
    600 pulses iTBS on motor cortex of suprahyoid muscle at ipsilateral side as the lesion for 15 minutes; sham stimulation on motor cortex of suprahyoid muscle at contra-lateral side as the lesion for 15 minutes.
    Arm Title
    control group of iTBS
    Arm Type
    Placebo Comparator
    Arm Description
    Sham stimulation on motor cortex of suprahyoid muscle at contra-lateral side as the lesion for 15 minutes.
    Intervention Type
    Device
    Intervention Name(s)
    repetitive transcranial magnetic stimulation(rTMS)
    Intervention Description
    5 hertz(Hz), 1000 pulses, 90% RMT stimulation; 15 minutes per session; for a total of 10 sessions
    Intervention Type
    Device
    Intervention Name(s)
    Intermittent Theta-burst Stimulation(iTBS)
    Intervention Description
    3 pulses of stimulation delivered at 50 Hz and repeated at 5 Hz; 2s train of TBS with repetitive interval of every 10s, 70% RMT; 600 pulses in total; 15 minutes per session; for a total of 10 sessions
    Intervention Type
    Device
    Intervention Name(s)
    Sham stimulation
    Intervention Description
    Set-up the coil without true stimulation; 15 minutes per session; for a total of 10 sessions
    Primary Outcome Measure Information:
    Title
    penetration-aspiration scale(PAS)
    Description
    Penetration-aspiration scale will be calculated by videofluoroscopic swallow study with measurement of the depth of penetrated or aspirated material and the patient's response to airway invasion. Score range is 1 to 8; higher score means more severe on penetration and aspiration.
    Time Frame
    Day 30 (change of PAS, comparing with the data in baseline) of each section
    Title
    penetration-aspiration scale(PAS)
    Description
    Penetration-aspiration scale will be calculated by videofluoroscopic swallow study with measurement of the depth of penetrated or aspirated material and the patient's response to airway invasion. Score range is 1 to 8; higher score means more severe on penetration and aspiration.
    Time Frame
    Day 90 (change of PAS, comparing with the data in baseline and Day 30) of each section
    Secondary Outcome Measure Information:
    Title
    The Swallowing Quality-of-Life questionnaire(SWAL-QOL)
    Description
    The questionnaire to assess ten quality-of-life concepts about dysphagia, containing 44-items and dividing into 10 domains. The score of each item ranges from 0 to 4 and total score ranges from 0 to 100. Higher score means better swallow-specific quality of life.
    Time Frame
    Day 14, Day 30, Day 90, Day 180 (comparing with the data in baseline) of each section
    Title
    The Functional Oral Intake Scale (FOIS)
    Description
    Measurement of functional level of oral intake of food and liquid with 7-point ordinal scale, level 1 to level 7. Higher level means better performance and lower limitation on oral intake.
    Time Frame
    Day 14, Day 30, Day 90, Day 180 (comparing with the data in baseline) of each section
    Title
    The Dysphagia Severity Scale (DSS)
    Description
    Combination of objective evaluation of the functional severity of dysphagia and recommendations for diet level. Level range is from 1 to 7; lower level means more severe on dysphagia and aspiration.
    Time Frame
    Day 14, Day 30, Day 90, Day 180 (comparing with the data in baseline) of each section
    Title
    Iowa Oral Performance Instrument (IOPI)
    Description
    Objectively evaluate and measure tongue and lip strength and endurance
    Time Frame
    Baseline, Day 14, Day 30, Day 90, Day 180
    Title
    Swallowing ultrasound
    Description
    The ultrasound of swallowing to evaluate the movement of hyoid bone
    Time Frame
    Baseline, Day 14, Day 30, Day 90, Day 180
    Title
    Motor evoked potential (MEP)
    Description
    Record the MEP of suprahyoid muscle under rTMS
    Time Frame
    Baseline, Day 14

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age > 20 years old, diagnosed of subcortical stroke(including ischemic or hemorrhagic type) by CT or MRI image study sustained the symptoms of dysphagia more than one month after stroke. Functional Oral Intake Scale (FOIS) between 1 to 5 score Maintenance on sitting balance over 15 minutes Exclusion Criteria: Disturbed consciousness, unable to communicate and obey order through gesture or language Disease or trauma involved central neural system, such as Parkinson's disease, traumatic brain injury, brain tumor or multiple sclerosis Any disorder inducing dysphagia, such as nasopharyngeal cancer(NPC) or cervical cancer Metal Implants or pacemaker Global aphasia or cognitive impairment History of epilepsy Pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ming-Yen Hsiao, PHD
    Phone
    23123456
    Ext
    52857
    Email
    myferrant@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ming-Yen Hsiao, PHD
    Organizational Affiliation
    Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taipei, Taiwan
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19833552
    Citation
    Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.
    Results Reference
    background
    PubMed Identifier
    35574927
    Citation
    Rao J, Li F, Zhong L, Wang J, Peng Y, Liu H, Wang P, Xu J. Bilateral Cerebellar Intermittent Theta Burst Stimulation Combined With Swallowing Speech Therapy for Dysphagia After Stroke: A Randomized, Double-Blind, Sham-Controlled, Clinical Trial. Neurorehabil Neural Repair. 2022 Jul;36(7):437-448. doi: 10.1177/15459683221092995. Epub 2022 May 16.
    Results Reference
    background
    PubMed Identifier
    35029231
    Citation
    Yu-Lei X, Shan W, Ju Y, Yu-Han X, Wu Q, Yin-Xu W. Theta burst stimulation versus high-frequency repetitive transcranial magnetic stimulation for poststroke dysphagia: A randomized, double-blind, controlled trial. Medicine (Baltimore). 2022 Jan 14;101(2):e28576. doi: 10.1097/MD.0000000000028576.
    Results Reference
    background
    PubMed Identifier
    35370584
    Citation
    Wen X, Liu Z, Zhong L, Peng Y, Wang J, Liu H, Gong X. The Effectiveness of Repetitive Transcranial Magnetic Stimulation for Post-stroke Dysphagia: A Systematic Review and Meta-Analysis. Front Hum Neurosci. 2022 Mar 17;16:841781. doi: 10.3389/fnhum.2022.841781. eCollection 2022.
    Results Reference
    background

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    rTMS in Chronic Poststroke Dysphagia

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