High-frequency Repetitive Transcranial Magnetic Stimulation for Patients With Dysphagia After Extubation (Dysphagia)

January 27, 2026 updated by: Qing Shu, Wuhan University

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.

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430070
        • Zhongnan hospital of Wuhan University, Wuhan, Hubei 430070

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age greater than 18 years;
  2. Tracheal intubation for more than 48 hours;
  3. Clear consciousness at the time of assessment, able to understand and follow the simple instructions of the researchers;
  4. Patients have dysphagia, and the Functional Oral Intake Scale (FOIS) assessment is at levels

Exclusion Criteria:

  1. Previous history of dysphagia;
  2. Undergoing tracheotomy;
  3. History of epilepsy;
  4. Having metal implants in the brain;
  5. Implanted with a cardiac pacemaker;
  6. Under absolute isolation (such as open or infectious pulmonary tuberculosis);

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: a bilateral high-frequency repetitive transcranial magnetic stimulation plus swallowing training
Behavioral: Swallowing training
Swallowing training includes facial function training, sensory stimulation training, and airway protection techniques.
Device: a bilateral high-frequency repetitive transcranial magnetic stimulation
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.
Placebo Comparator: Swallowing training plus No intervention
Behavioral: Swallowing training
Swallowing training includes facial function training, sensory stimulation training, and airway protection techniques.
Other: No intervention
No intervention methods

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (before treatment), 3 days after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wakada Drinking Water Test，WST
Time Frame: Baseline (before treatment), 3 days after treatment
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
Baseline (before treatment), 3 days after treatment
degree of swallowing difficulty，GUSS
Time Frame: Baseline (before treatment), 3 days after treatment
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.
Baseline (before treatment), 3 days after treatment
length of stay
Time Frame: at discharge
The earlier a patient is discharged, the less financial burden it will impose on them
at discharge

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence rate of pneumonia
Time Frame: 30 days after extubation
A lower incidence of pneumonia indicates fewer complications
30 days after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025169K

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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