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Repetitive Transcranial Magnetic Stimulation on Dysphagia in the Stroke Patient

Primary Purpose

Stroke, Dysphagia, Repetitive Transcranial Magnetic Stimulation

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Neuromuscular electrical stimulation combined with conventional swallowing training
Sponsored by
Taipei Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: stroke Onset time at least for one week,area not be limited. Patient was first time stroke patient without obvious infection condition. Patients with dysphagia in the stroke who were diagnosed by neurologist and CT/MRI in our institute. Patient was clear with adequate motivation and could cooperate the whole therapy and FEES evaluation. Exclusion Criteria: Lower motor neuron disease, such as autonomic dysreflexia, facial palsy, hyhoid muscle denervation. Mental status unstable, mental retardation, schizophrenia, bipolar disease were be excluded. Metal implantation of head, ventroperotoneal shunt or any seizure history, pacemaker, as well as head and neck cancer. Allergy to specific subjects Cognition impairment Alcohol or drugs abuse Afraid of the noise of rTMS.

Sites / Locations

  • Taipei Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Group A

Group B

Arm Description

Conscript 10 individuals, every individual will receive 20 mins of repetitive transcranial magnetic stimulation and 30 min NMES combined with conventional swallowing therapy, 5 times per week, lasting for 2 weeks.

Conscript 10 individuals, every individual will receive sham repetitive transcranial magnetic stimulation and 30 min NMES combined with conventional swallowing therapy, 5 times per week, lasting for 2 weeks.

Outcomes

Primary Outcome Measures

Change from baseline in Fiberoptic Endoscopic Examination of Swallowing (FEES) at 2 weeks
In this study, FEES is executed before and after intervention. The assessment of FEES is as follows. Hyodo-score: for predicting aspiration with moderate sensitivity and high specificity. This method consists of four parameters; These four parameters are each scored 0-3 on a 4 point scale (0; normal, 1; mildly impaired, 2; moderately impaired, 3; severely impaired). The Hyodo score is expressed as the sum of scores for each of the four parameters, ranging 0- 12. Patients with a score of less than 5 were assessed as having normal swallowing function. Patients with a score of more than 8 had severe swallowing dysfunction and would not be allowed any oral intake.
Change from baseline in The Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) at 2 weeks
The Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS): Stroke-related dysphagia was divided into a six-point FEDSS with 1 score for the best and 6 scores for the worst.
Change of baseline Standardized Swallowing Assessment (SSA) at 2 weeks
In this study, SSA was executed before and after intervention. SSA is a standard of universal screening of all stroke patients within 24 hours of admission. And SSA comprises three sections and was designed to terminate if a problem was encountered. The first section checked whether the patient was physically capable of screening; sections 2 and 3 comprised the main screening test. Volitional cough, saliva control, oral motor dexterity, respiratory compromise and phonation were first evaluated; if no problems were elicited, the ability to swallow water was observed.
Change of baseline Latency of Motor evoked potentials (MEP) at 2 weeks
Onset latency of MEP, The latency, however, may provide information about the stress in damaged motor pathways.
Change of baseline Amplitude of Motor evoked potentials (MEP) at 2 weeks
Onset to peak amplitude of Motor evoked potentials (MEP).The amplitude of motor evoked potentials (MEPs) elicited by transcranial magnetic stimulation (TMS) is a common yet highly variable measure of corticospinal excitability.

Secondary Outcome Measures

Change of baseline Degree of dysphagia at 2 weeks
Score of degree of dysphagia, score 0 shows normal swallowing, score 1 is able to swallow , some solid food, score 2 is able to swallow semi-liquid food, score 3 is able to swallow liquids only, score 4 exhibits absolute dysphagia.
Change of Functional Oral Intake Scale (FOIS) at 2 weeks
Functional Oral Intake Scale
Change of baseline modified water swallowing test at 2 weeks
modified water swallowing test

Full Information

First Posted
January 19, 2023
Last Updated
May 16, 2023
Sponsor
Taipei Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05861596
Brief Title
Repetitive Transcranial Magnetic Stimulation on Dysphagia in the Stroke Patient
Official Title
Effects of Repetitive Transcranial Magnetic Stimulation on Dysphagia in Individuals With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 23, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Participants suffered from acute stroke with dysphagia in single hospital who were determined by CT/MRI and clinical evaluation. Current project will recruit participants and randomize into two groups.One group will receive NMES, traditional swallowing therapy and rTMS therapy five times per week for 2 weeks ; Another group will receive NMES and traditional swallowing therapy with shame rTMS five times per week for 2 weeks. FEES and SSA were used for evaluated swallowing function before the therapy and after 2 weeks therapy.
Detailed Description
Participants suffered from acute stroke with dysphagia in single hospital who were determined by CT/MRI and clinical evaluation. The aim of this study is to compare the effects of rTMS, NMES and conventional swallowing therapy to those of sham rTMS, NMES and conventional swallowing therapy. One group will receive NMES, to sham One group will receive NMES,traditional swallowing therapy and rTMS therapy five times per week for 2 weeks ; Another group will receive NMES and traditional swallowing therapy with shame rTMS five times per week for 2 weeks. MEP character, FEES, degrees of dysphagia, FOIS, and SSA were used for evaluated swallowing function before the therapy and after 2 weeks therapy.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Conscript 10 individuals, every individual will receive 20 mins of repetitive transcranial magnetic stimulation and 30 min NMES combined with conventional swallowing therapy, 5 times per week, lasting for 2 weeks.
Arm Title
Group B
Arm Type
Sham Comparator
Arm Description
Conscript 10 individuals, every individual will receive sham repetitive transcranial magnetic stimulation and 30 min NMES combined with conventional swallowing therapy, 5 times per week, lasting for 2 weeks.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Intervention Description
Participants suffered from acute stroke with dysphagia in single hospital who were determined by CT/MRI and clinical evaluation. The aim of this study is to compare the effects of rTMS, Neuromuscular electrical stimulation (NMES) and conventional swallowing therapy to those of sham rTMS, Neuromuscular electrical stimulation(NMES) and conventional swallowing therapy. One group will receive Neuromuscular electrical stimulation(NMES), to sham One group will receive Neuromuscular electrical stimulation(NMES),traditional swallowing therapy and rTMS therapy five times per week for 2 weeks ; Another group will receive Neuromuscular electrical stimulation(NMES) and traditional swallowing therapy with shame rTMS five times per week for 2 weeks. MEP character, FEES, degrees of dysphagia, FOIS, and SSA were used for evaluated swallowing function before the therapy and after 2 weeks therapy.
Intervention Type
Device
Intervention Name(s)
Neuromuscular electrical stimulation combined with conventional swallowing training
Intervention Description
Participants suffered from acute stroke with dysphagia in single hospital who were determined by CT/MRI and clinical evaluation. The aim of this study is to compare the effects of rTMS, Neuromuscular electrical stimulation (NMES) and conventional swallowing therapy to those of sham rTMS, Neuromuscular electrical stimulation(NMES) and conventional swallowing therapy. One group will receive Neuromuscular electrical stimulation(NMES), to sham One group will receive Neuromuscular electrical stimulation(NMES),traditional swallowing therapy and rTMS therapy five times per week for 2 weeks ; Another group will receive Neuromuscular electrical stimulation(NMES) and traditional swallowing therapy with shame rTMS five times per week for 2 weeks. MEP character, FEES, degrees of dysphagia, FOIS, and SSA were used for evaluated swallowing function before the therapy and after 2 weeks therapy.
Primary Outcome Measure Information:
Title
Change from baseline in Fiberoptic Endoscopic Examination of Swallowing (FEES) at 2 weeks
Description
In this study, FEES is executed before and after intervention. The assessment of FEES is as follows. Hyodo-score: for predicting aspiration with moderate sensitivity and high specificity. This method consists of four parameters; These four parameters are each scored 0-3 on a 4 point scale (0; normal, 1; mildly impaired, 2; moderately impaired, 3; severely impaired). The Hyodo score is expressed as the sum of scores for each of the four parameters, ranging 0- 12. Patients with a score of less than 5 were assessed as having normal swallowing function. Patients with a score of more than 8 had severe swallowing dysfunction and would not be allowed any oral intake.
Time Frame
one day before intervention, 1 day after intervention
Title
Change from baseline in The Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) at 2 weeks
Description
The Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS): Stroke-related dysphagia was divided into a six-point FEDSS with 1 score for the best and 6 scores for the worst.
Time Frame
one day before intervention, 1 day after intervention
Title
Change of baseline Standardized Swallowing Assessment (SSA) at 2 weeks
Description
In this study, SSA was executed before and after intervention. SSA is a standard of universal screening of all stroke patients within 24 hours of admission. And SSA comprises three sections and was designed to terminate if a problem was encountered. The first section checked whether the patient was physically capable of screening; sections 2 and 3 comprised the main screening test. Volitional cough, saliva control, oral motor dexterity, respiratory compromise and phonation were first evaluated; if no problems were elicited, the ability to swallow water was observed.
Time Frame
one day before intervention, 1 day after intervention
Title
Change of baseline Latency of Motor evoked potentials (MEP) at 2 weeks
Description
Onset latency of MEP, The latency, however, may provide information about the stress in damaged motor pathways.
Time Frame
one day before intervention, 1 day after intervention
Title
Change of baseline Amplitude of Motor evoked potentials (MEP) at 2 weeks
Description
Onset to peak amplitude of Motor evoked potentials (MEP).The amplitude of motor evoked potentials (MEPs) elicited by transcranial magnetic stimulation (TMS) is a common yet highly variable measure of corticospinal excitability.
Time Frame
one day before intervention, 1 day after intervention.
Secondary Outcome Measure Information:
Title
Change of baseline Degree of dysphagia at 2 weeks
Description
Score of degree of dysphagia, score 0 shows normal swallowing, score 1 is able to swallow , some solid food, score 2 is able to swallow semi-liquid food, score 3 is able to swallow liquids only, score 4 exhibits absolute dysphagia.
Time Frame
one day before intervention, 1 day after intervention
Title
Change of Functional Oral Intake Scale (FOIS) at 2 weeks
Description
Functional Oral Intake Scale
Time Frame
one day before intervention, 1 day after intervention
Title
Change of baseline modified water swallowing test at 2 weeks
Description
modified water swallowing test
Time Frame
one day before intervention, 1 day after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: stroke Onset time at least for one week,area not be limited. Patient was first time stroke patient without obvious infection condition. Patients with dysphagia in the stroke who were diagnosed by neurologist and CT/MRI in our institute. Patient was clear with adequate motivation and could cooperate the whole therapy and FEES evaluation. Exclusion Criteria: Lower motor neuron disease, such as autonomic dysreflexia, facial palsy, hyhoid muscle denervation. Mental status unstable, mental retardation, schizophrenia, bipolar disease were be excluded. Metal implantation of head, ventroperotoneal shunt or any seizure history, pacemaker, as well as head and neck cancer. Allergy to specific subjects Cognition impairment Alcohol or drugs abuse Afraid of the noise of rTMS.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chien-Hung Lai, MD, PhD
Phone
02-27372181
Ext
3243
Email
chlai@tmu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Chieh Chen, MD
Phone
+886933235048
Email
garyrbc@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chien-Hung Lai, MD, PhD
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, Taipei Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University Hospital
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chien-Hung Lai, PhD
Phone
+886-2-27372181
Ext
1236
Email
chlai@tmu.edu.tw
First Name & Middle Initial & Last Name & Degree
Chien-Hung Lai, PhD

12. IPD Sharing Statement

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Repetitive Transcranial Magnetic Stimulation on Dysphagia in the Stroke Patient

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