StrokeNCT05861596
Repetitive Transcranial Magnetic Stimulation on Dysphagia in the Stroke Patient
A study testing Repetitive Transcranial Magnetic Stimulation and Neuromuscular electrical stimulation combined with conventional swallowing training in people with Stroke and Dysphagia, run by Taipei Medical University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Stroke, Dysphagia, Repetitive Transcranial Magnetic Stimulation
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation and Neuromuscular electrical stimulation combined with conventional swallowing training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Nov 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Hospital
Taipei, 110
Chien-Hung Lai, PhD, +886-2-27372181 ext. 1236, chlai@tmu.edu.tw
Chien-Hung Lai, PhD
About this study
Official title: 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.
Read the 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.
- Being tested
- Repetitive Transcranial Magnetic Stimulation, Neuromuscular electrical stimulation combined with conventional swallowing training
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
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 trainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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. Receives: Device: Repetitive Transcranial Magnetic Stimulation; Device: Neuromuscular electrical stimulation combined with conventional swallowing training |
| Group B | Sham comparator | 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. Receives: Device: Neuromuscular electrical stimulation combined with conventional swallowing training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: one day before intervention, 1 day after intervention.
Secondary outcomes (3)
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.
Measured: one day before intervention, 1 day after intervention
Change of Functional Oral Intake Scale (FOIS) at 2 weeks
Functional Oral Intake Scale
Measured: one day before intervention, 1 day after intervention
Change of baseline modified water swallowing test at 2 weeks
modified water swallowing test
Measured: one day before intervention, 1 day after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start23 Nov 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lai chien hung, Taipei Medical University Hospital
- Investigators
- Chien-Hung Lai, MD, PhD, Principal investigator, Department of Physical Medicine and Rehabilitation, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861596
- Sponsor's protocol ID
- N201912080
- Status last verified
- May 2023
- First submitted
- 19 Jan 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Repetitive Transcranial Magnetic Stimulation on Dysphagia in Individuals With Stroke
- ClinicalTrials.gov ID
- NCT05861596
- Acronym / sponsor ID
- N201912080
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Repetitive Transcranial Magnetic Stimulation, Device: Neuromuscular electrical stimulation combined with conventional swallowing trainingConscript 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. |
| Group B | Sham comparator | Device: Neuromuscular electrical stimulation combined with conventional swallowing trainingConscript 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationParticipants 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 | Group A |
| Neuromuscular electrical stimulation combined with conventional swallowing trainingParticipants 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 | Group A, Group B |
Primary outcome
Change from baseline in Fiberoptic Endoscopic Examination of Swallowing (FEES) at 2 weeks
Time frame: one day before intervention, 1 day after intervention
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
Time frame: one day before intervention, 1 day after intervention
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
Time frame: one day before intervention, 1 day after intervention
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
Time frame: one day before intervention, 1 day after intervention
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
Time frame: one day before intervention, 1 day after intervention.
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.
3 secondary outcomes
Change of baseline Degree of dysphagia at 2 weeks
Time frame: one day before intervention, 1 day after intervention
Change of Functional Oral Intake Scale (FOIS) at 2 weeks
Time frame: one day before intervention, 1 day after intervention
Change of baseline modified water swallowing test at 2 weeks
Time frame: one day before intervention, 1 day after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chien-Hung Lai, MD, PhD principal investigator
Department of Physical Medicine and Rehabilitation, Taipei Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation and Neuromuscular electrical stimulation combined with conventional swallowing training in people with Stroke and Dysphagia, run by Taipei Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chien-Hung Lai, MD, PhD (02-27372181 ext. 3243, chlai@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Fiberoptic Endoscopic Examination of Swallowing (FEES) at 2 weeks (time frame: one day before intervention, 1 day after intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.