Deglutition DisordersNCT05590819
rTMS in Chronic Poststroke Dysphagia
A study testing repetitive transcranial magnetic stimulation(rTMS) and Intermittent Theta-burst Stimulation(iTBS) in people with Deglutition Disorders, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Deglutition Disorders
- What is being tested?
- repetitive transcranial magnetic stimulation(rTMS) and Intermittent Theta-burst Stimulation(iTBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 5 Feb 2023to 31 Aug 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Poststroke Dysphagia.
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.
Read the 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.
- Conditions
- Deglutition Disorders
- Being tested
- repetitive transcranial magnetic stimulation(rTMS), Intermittent Theta-burst Stimulation(iTBS), Sham stimulation
- Keywords
- Transcranial Magnetic Stimulation, Dysphagia, Stroke
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulation(rTMS)Device
5 hertz(Hz), 1000 pulses, 90% RMT stimulation; 15 minutes per session; for a total of 10 sessions
Intermittent Theta-burst Stimulation(iTBS)Device
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
Sham stimulationDevice
Set-up the coil without true stimulation; 15 minutes per session; for a total of 10 sessions
| Study group | Role | What they receive |
|---|---|---|
| bilateral rTMS | Experimental | 5 hertz(Hz), 1000 pulses, 90% resting motor threshold(RMT) stimulation on bilateral motor cortex of suprahyoid muscle for 15 minutes. Receives: Device: repetitive transcranial magnetic stimulation(rTMS) |
| unilateral rTMS | Experimental | 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. Receives: Device: repetitive transcranial magnetic stimulation(rTMS) |
| control group of rTMS | Placebo comparator | Sham stimulation on motor cortex of suprahyoid muscle at contra-lateral side as the lesion for 15 minutes. Receives: Device: Sham stimulation |
| bilateral iTBS | Experimental | 600 pulses iTBS stimulation on bilateral motor cortex of suprahyoid muscle for 15 minutes. Receives: Device: Intermittent Theta-burst Stimulation(iTBS) |
| unilateral iTBS | Experimental | 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. Receives: Device: Intermittent Theta-burst Stimulation(iTBS) |
| control group of iTBS | Placebo comparator | Sham stimulation on motor cortex of suprahyoid muscle at contra-lateral side as the lesion for 15 minutes. Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 30 (change of PAS, comparing with the data in baseline) of each section
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.
Measured: Day 90 (change of PAS, comparing with the data in baseline and Day 30) of each section
Secondary outcomes (6)
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.
Measured: Day 14, Day 30, Day 90, Day 180 (comparing with the data in baseline) of each section
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.
Measured: Day 14, Day 30, Day 90, Day 180 (comparing with the data in baseline) of each section
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.
Measured: Day 14, Day 30, Day 90, Day 180 (comparing with the data in baseline) of each section
Iowa Oral Performance Instrument (IOPI)
Objectively evaluate and measure tongue and lip strength and endurance
Measured: Baseline, Day 14, Day 30, Day 90, Day 180
Swallowing ultrasound
The ultrasound of swallowing to evaluate the movement of hyoid bone
Measured: Baseline, Day 14, Day 30, Day 90, Day 180
Motor evoked potential (MEP)
Record the MEP of suprahyoid muscle under rTMS
Measured: Baseline, Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start5 Feb 2023 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Deglutition DisordersStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming-Yen Hsiao, PHD, Study chair, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590819
- Sponsor's protocol ID
- 202107115DINC
- Status last verified
- Sep 2022
- First submitted
- 6 Oct 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19833552Rao 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.
PubMed 35574927Yu-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.
PubMed 35029231Wen 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.
PubMed 35370584
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Poststroke Dysphagia.
- ClinicalTrials.gov ID
- NCT05590819
- Acronym / sponsor ID
- 202107115DINC
- Conditions
- Deglutition Disorders
- Keywords
- Transcranial Magnetic Stimulation, Dysphagia, Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 5 Feb 2023 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 21 Oct 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| bilateral rTMS | Experimental | Device: repetitive transcranial magnetic stimulation(rTMS)5 hertz(Hz), 1000 pulses, 90% resting motor threshold(RMT) stimulation on bilateral motor cortex of suprahyoid muscle for 15 minutes. |
| unilateral rTMS | Experimental | Device: repetitive transcranial magnetic stimulation(rTMS)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. |
| control group of rTMS | Placebo comparator | Device: Sham stimulationSham stimulation on motor cortex of suprahyoid muscle at contra-lateral side as the lesion for 15 minutes. |
| bilateral iTBS | Experimental | Device: Intermittent Theta-burst Stimulation(iTBS)600 pulses iTBS stimulation on bilateral motor cortex of suprahyoid muscle for 15 minutes. |
| unilateral iTBS | Experimental | Device: Intermittent Theta-burst Stimulation(iTBS)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. |
| control group of iTBS | Placebo comparator | Device: Sham stimulationSham stimulation on motor cortex of suprahyoid muscle at contra-lateral side as the lesion for 15 minutes. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 stimulation(rTMS)5 hertz(Hz), 1000 pulses, 90% RMT stimulation; 15 minutes per session; for a total of 10 sessions | Device | bilateral rTMS, unilateral rTMS |
| Intermittent Theta-burst Stimulation(iTBS)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 | Device | bilateral iTBS, unilateral iTBS |
| Sham stimulationSet-up the coil without true stimulation; 15 minutes per session; for a total of 10 sessions | Device | control group of iTBS, control group of rTMS |
Primary outcome
penetration-aspiration scale(PAS)
Time frame: Day 30 (change of PAS, comparing with the data in baseline) of each section
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)
Time frame: Day 90 (change of PAS, comparing with the data in baseline and Day 30) of each section
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.
6 secondary outcomes
The Swallowing Quality-of-Life questionnaire(SWAL-QOL)
Time frame: Day 14, Day 30, Day 90, Day 180 (comparing with the data in baseline) of each section
The Functional Oral Intake Scale (FOIS)
Time frame: Day 14, Day 30, Day 90, Day 180 (comparing with the data in baseline) of each section
The Dysphagia Severity Scale (DSS)
Time frame: Day 14, Day 30, Day 90, Day 180 (comparing with the data in baseline) of each section
Iowa Oral Performance Instrument (IOPI)
Time frame: Baseline, Day 14, Day 30, Day 90, Day 180
Swallowing ultrasound
Time frame: Baseline, Day 14, Day 30, Day 90, Day 180
Motor evoked potential (MEP)
Time frame: Baseline, Day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Background: PubMed 19833552Rossi 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.
- Background: PubMed 35574927Rao 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.
- Background: PubMed 35029231Yu-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.
- Background: PubMed 35370584Wen 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.
- Individual participant dataSharing planned: No
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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.
Ming-Yen Hsiao, PHD study chair
Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taipei, Taiwan
Questions about this trial
What is this clinical trial studying?
A study testing repetitive transcranial magnetic stimulation(rTMS) and Intermittent Theta-burst Stimulation(iTBS) in people with Deglutition Disorders, run by National Taiwan University Hospital.
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 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Ming-Yen Hsiao, PHD (23123456 ext. 52857, myferrant@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
penetration-aspiration scale(PAS) (time frame: Day 30 (change of PAS, comparing with the data in baseline) of each section). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05590819, which also lists 4 linked publications.
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 2 Feb 2023.