Repetitive Transcranial Magnetic Stimulation on Dysphagia in the Stroke Patient

Effects of Repetitive Transcranial Magnetic Stimulation on Dysphagia in Individuals With Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Dysphagia; Repetitive Transcranial Magnetic Stimulation
• Intervention / Treatment: Device: Repetitive Transcranial Magnetic Stimulation; Device: Neuromuscular electrical stimulation combined with conventional swallowing training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chien-Hung Lai, MD, PhD; Phone Number: 3243 02-27372181; Email: chlai@tmu.edu.tw
• Study Contact Backup: Name: Chieh Chen, MD; Phone Number: +886933235048; Email: garyrbc@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Recruiting
    • Taipei Medical University Hospital
    • Contact: Chien-Hung Lai, PhD; Phone Number: 1236 +886-2-27372181; Email: chlai@tmu.edu.tw
    • Principal Investigator: Chien-Hung Lai, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. stroke
2. Onset time at least for one week，area not be limited.
3. Patient was first time stroke patient without obvious infection condition.
4. 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:

1. Lower motor neuron disease, such as autonomic dysreflexia, facial palsy, hyhoid muscle denervation.
2. Mental status unstable, mental retardation, schizophrenia, bipolar disease were be excluded.
3. Metal implantation of head, ventroperotoneal shunt or any seizure history, pacemaker, as well as head and neck cancer.
4. Allergy to specific subjects
5. Cognition impairment
6. Alcohol or drugs abuse
7. Afraid of the noise of rTMS.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; 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.	Device: Repetitive Transcranial Magnetic Stimulation; 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.; Device: Neuromuscular electrical stimulation combined with conventional swallowing training; 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.
Sham Comparator: Group B; 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.	Device: Neuromuscular electrical stimulation combined with conventional swallowing training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one day before intervention, 1 day after intervention
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.	one day before intervention, 1 day after intervention
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.	one day before intervention, 1 day after intervention
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.	one day before intervention, 1 day after intervention
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.	one day before intervention, 1 day after intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one day before intervention, 1 day after intervention
Change of Functional Oral Intake Scale (FOIS) at 2 weeks	Functional Oral Intake Scale	one day before intervention, 1 day after intervention
Change of baseline modified water swallowing test at 2 weeks	modified water swallowing test	one day before intervention, 1 day after intervention

Collaborators and Investigators

• Sponsor: Taipei Medical University Hospital
• Investigators: Principal Investigator: Chien-Hung Lai, MD, PhD, Department of Physical Medicine and Rehabilitation, Taipei Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2022
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Stroke; Deglutition Disorders
• Other Study ID Numbers: N201912080

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No