Post-extubation DysphagiaDysphagiaNCT07381946
High-frequency Repetitive Transcranial Magnetic Stimulation for Patients With Dysphagia After Extubation
A study testing Swallowing training and a bilateral high-frequency repetitive transcranial magnetic stimulation in people with Post-extubation Dysphagia, run by Wuhan University at 1 site in China.
Trial summary
Post-extubation dysphagia (PED) is characterized by a range of clinical manifestations, including absence of visible swallowing effort, coughing or choking following liquid intake, and post-swallowing dysarthria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-extubation Dysphagia
- What is being tested?
- Swallowing training and a bilateral high-frequency repetitive transcranial magnetic stimulation
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years;
- Tracheal intubation for more than 48 hours;
- Clear consciousness at the time of assessment, able to understand and follow the simple instructions of the researchers;
- Patients have dysphagia, and the Functional Oral Intake Scale (FOIS) assessment is at levels
Who cannot join
- Previous history of dysphagia;
- Undergoing tracheotomy;
- History of epilepsy;
- Having metal implants in the brain;
- Implanted with a cardiac pacemaker;
- Under absolute isolation (such as open or infectious pulmonary tuberculosis);
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongnan hospital of Wuhan University, Wuhan, Hubei 430070
Wuhan, Hubei, 430070
About this study
Official title: Clinical Study on Bilateral High-frequency Repetitive Transcranial Magnetic Stimulation Combined With Swallowing Training for Patients With Dysphagia After Extubation
Post-extubation dysphagia (PED) is characterized by a range of clinical manifestations, including absence of visible swallowing effort, coughing or choking following liquid intake, and post-swallowing dysarthria. These impairments may lead to severe complications such as aspiration pneumonia, electrolyte disturbances, and malnutrition. Currently, the majority of hospitals both domestically and internationally have not implemented routine screening for PED or standardized swallowing rehabilitation programs, and research on the recovery of swallowing function in PED remains limited. This study aims to investigate the therapeutic efficacy of bilateral high-frequency repetitive transcranial magnetic stimulation (rTMS) combined with conventional swallowing training in patients with PED, and to evaluate the influence of oral feeding on functional recovery and the incidence of pneumonia.
The study design is a single-center, randomized, single-blind, parallel-controlled trial. Participants with PED will be randomly assigned to either a swallowing training group or a bilateral high-frequency repetitive transcranial magnetic stimulation plus swallowing training group.The primary outcome measure is the Functional Oral Intake Scale (FOIS) score，which assesses oral feeding ability.Secondary outcomes include the Wakada Drinking Water Test(WST),degree of swallowing difficulty(GUSS),the incidence rate of pneumonia and length of stay.These secondary outcomes will provide a comprehensive evaluation of swallowing ability and hospitalization effects.
Read more
Random grouping was conducted within 4 hours after extubation, and the treatment began within 2 hours and lasted for 3 consecutive days.Each rTMS session will target key brain regions.Swallowing training includes facial function training, sensory stimulation training, and airway protection techniques.The observation group received bilateral high-frequency transcranial magnetic stimulation in addition to the swallowing training.The data will be collected before and after the treatment.The primary outcome, FOIS score, will be used to assess the overall improvement in oral feeding ability.WST and GUSS data will be collected to evaluate a comprehensive evaluation of swallowing ability.The incidence rate of pneumonia and length of stay will be used to assess change in side effects.
Statistical analyses will be performed using SPSS 22.0. Data will be presented as mean ± standard deviation. Between-group differences will be compared using independent samples t-tests.
The study timeline spans from September 2025 to December 2026, including participant recruitment, intervention implementation, data collection, and analysis, as well as manuscript drafting. This study aims to provide new insights into the treatment methods for PED and explore a new rehabilitation approach that can be used in the ICU, with the expectation of improving swallowing disorders and reducing complications.
- Conditions
- Post-extubation Dysphagia
- Being tested
- Swallowing training, a bilateral high-frequency repetitive transcranial magnetic stimulation, No intervention
- Keywords
- Dysphagia, Extubation failure, repetitive transcranial magnetic stimulation
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swallowing trainingBehavioural
Swallowing training includes facial function training, sensory stimulation training, and airway protection techniques.
a bilateral high-frequency repetitive transcranial magnetic stimulationDevice
The interventional targets were the key cortical brain regions identified in preliminary studies, with stimulation applied to the bilateral oral and tongue regions.Parameters included a figure-of-8 coil, 10 Hz frequency, 5-second stimulation duration,55-second inter-train intervals, 10 repetitions, totaling 500 pulses per session, with each session lasting 10 minutes. Swallowing Training commenced within 10 minutes post-rTMS, following the same duration and intensity as the Swallowing Training Group . The treatment was conducted three days.
No interventionOther
No intervention methods
| Study group | Role | What they receive |
|---|---|---|
| a bilateral high-frequency repetitive transcranial magnetic stimulation plus swallowing training | Experimental | Not described Receives: Behavioral: Swallowing training; Device: a bilateral high-frequency repetitive transcranial magnetic stimulation |
| Swallowing training plus No intervention | Placebo comparator | Not described Receives: Behavioral: Swallowing training; Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Oral Intake Scale ，FOIS
The oral feeding ability was conducted using the Functional Oral Intake Scale (FOIS), which is divided into 7 levels. The higher the level, the better the oral intake ability.
Measured: Baseline (before treatment), 3 days after treatment
Secondary outcomes (3)
Wakada Drinking Water Test，WST
The swallowing function was evaluated using the WST. The classification ranges from level 1 to level 5. The higher the level, the poorer the drinking ability
Measured: Baseline (before treatment), 3 days after treatment
degree of swallowing difficulty，GUSS
The GUSS is a widely used assessment tool for evaluating functional outcomes in dysphagia. It includes domains such as attention, spontaneous coughing, swallowing saliva, drooling, and voice.The direct swallowing test section involves screening for the swallowing of thickened food, liquid food, and solid food, respectively, to assess the situations of delayed swallowing, spontaneous coughing, drooling, and voice changes.The total score is 20 points, with 0 to 9 points indicating severe dysphagia; 10 to 14 points indicating moderate dysphagia; 15 to 19 points indicating mild dysphagia; and 20 points indicating no dysphagia.
Measured: Baseline (before treatment), 3 days after treatment
length of stay
The earlier a patient is discharged, the less financial burden it will impose on them
Measured: at discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Sep 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-extubation DysphagiaStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing Shu, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381946
- Sponsor's protocol ID
- 2025169K
- Acronym
- Dysphagia
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Bilateral High-frequency Repetitive Transcranial Magnetic Stimulation Combined With Swallowing Training for Patients With Dysphagia After Extubation
- ClinicalTrials.gov ID
- NCT07381946
- Acronym / sponsor ID
- Dysphagia / 2025169K
- Conditions
- Post-extubation Dysphagia
- Keywords
- Dysphagia, Extubation failure, repetitive transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wuhan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 Feb 2026 (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.
Post-extubation dysphagia (PED) is characterized by a range of clinical manifestations, including absence of visible swallowing effort, coughing or choking following liquid intake, and post-swallowing dysarthria. These impairments may lead to severe complications such as aspiration pneumonia, electrolyte disturbances, and malnutrition. Currently, the majority of hospitals both domestically and internationally have not implemented routine screening for PED or standardized swallowing rehabilitation programs, and research on the recovery of swallowing function in PED remains limited. This study aims to investigate the therapeutic efficacy of bilateral high-frequency repetitive transcranial magnetic stimulation (rTMS) combined with conventional swallowing training in patients with PED, and to evaluate the influence of oral feeding on functional recovery and the incidence of pneumonia.
The study design is a single-center, randomized, single-blind, parallel-controlled trial. Participants with PED will be randomly assigned to either a swallowing training group or a bilateral high-frequency repetitive transcranial magnetic stimulation plus swallowing training group.The primary outcome measure is the Functional Oral Intake Scale (FOIS) score，which assesses oral feeding ability.Secondary outcomes include the Wakada Drinking Water Test(WST),degree of swallowing difficulty(GUSS),the incidence rate of pneumonia and length of stay.These secondary outcomes will provide a comprehensive evaluation of swallowing ability and hospitalization effects.
Random grouping was conducted within 4 hours after extubation, and the treatment began within 2 hours and lasted for 3 consecutive days.Each rTMS session will target key brain regions.Swallowing training includes facial function training, sensory stimulation training, and airway protection techniques.The observation group received bilateral high-frequency transcranial magnetic stimulation in addition to the swallowing training.The data will be collected before and after the treatment.The primary outcome, FOIS score, will be used to assess the overall improvement in oral feeding ability.WST and GUSS data will be collected to evaluate a comprehensive evaluation of swallowing ability.The incidence rate of pneumonia and length of stay will be used to assess change in side effects.
Statistical analyses will be performed using SPSS 22.0. Data will be presented as mean ± standard deviation. Between-group differences will be compared using independent samples t-tests.
The study timeline spans from September 2025 to December 2026, including participant recruitment, intervention implementation, data collection, and analysis, as well as manuscript drafting. This study aims to provide new insights into the treatment methods for PED and explore a new rehabilitation approach that can be used in the ICU, with the expectation of improving swallowing disorders and reducing complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a bilateral high-frequency repetitive transcranial magnetic stimulation plus swallowing training | Experimental | Behavioral: Swallowing training, Device: a bilateral high-frequency repetitive transcranial magnetic stimulation |
| Swallowing training plus No intervention | Placebo comparator | Behavioral: Swallowing training, Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than 18 years;
- Tracheal intubation for more than 48 hours;
- Clear consciousness at the time of assessment, able to understand and follow the simple instructions of the researchers;
- Patients have dysphagia, and the Functional Oral Intake Scale (FOIS) assessment is at levels
Key exclusion criteria (6 listed)
- Previous history of dysphagia;
- Undergoing tracheotomy;
- History of epilepsy;
- Having metal implants in the brain;
- Implanted with a cardiac pacemaker;
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 |
|---|---|---|
| Swallowing trainingSwallowing training includes facial function training, sensory stimulation training, and airway protection techniques. | Behavioural | Swallowing training plus No intervention, a bilateral high-frequency repetitive transcranial magnetic stimulation plus swallowing training |
| a bilateral high-frequency repetitive transcranial magnetic stimulationThe interventional targets were the key cortical brain regions identified in preliminary studies, with stimulation applied to the bilateral oral and tongue regions.Parameters included a figure-of-8 coil, 10 Hz frequency, 5-second stimulation duration,55-second inter-train intervals, 10 repetitions, totaling 500 pulses per session, with each session lasting 10 minutes. Swallowing Training commenced within 10 minutes post-rTMS, following the same duration and intensity as the Swallowing Training Group . The treatment was conducted three days. | Device | a bilateral high-frequency repetitive transcranial magnetic stimulation plus swallowing training |
| No interventionNo intervention methods | Other | Swallowing training plus No intervention |
Primary outcome
Functional Oral Intake Scale ，FOIS
Time frame: Baseline (before treatment), 3 days after treatment
The oral feeding ability was conducted using the Functional Oral Intake Scale (FOIS), which is divided into 7 levels. The higher the level, the better the oral intake ability.
3 secondary outcomes
Wakada Drinking Water Test，WST
Time frame: Baseline (before treatment), 3 days after treatment
degree of swallowing difficulty，GUSS
Time frame: Baseline (before treatment), 3 days after treatment
length of stay
Time frame: at discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swallowing training and a bilateral high-frequency repetitive transcranial magnetic stimulation in people with Post-extubation Dysphagia, run by Wuhan University at 1 site in China.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 2 Feb 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Oral Intake Scale ，FOIS (time frame: Baseline (before treatment), 3 days after treatment). 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 2 Feb 2026.