Repetitive Transcranial Magnetic Stimulation on Dysphagia in the Stroke Patient

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05861596
• Other study ID #: N201912080
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2023
• Source: Taipei Medical University Hospital
• Contact: Chien-Hung Lai, MD, PhD
• Phone: 02-27372181
• Email: chlai[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Repetitive Transcranial Magnetic Stimulation
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Change of Functional Oral Intake Scale (FOIS) at 2 weeks	Functional Oral Intake Scale	one day before intervention, 1 day after intervention
Secondary	Change of baseline modified water swallowing test at 2 weeks	modified water swallowing test	one day before intervention, 1 day after intervention