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

NCT07381946 | Active Not Recruiting

• 1 other identifier: 2025169K
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Post-extubation Dysphagia

Keywords

Dysphagia; Extubation failure; repetitive transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (before treatment), 3 days after treatment

Secondary Outcomes (3)

• Wakada Drinking Water Test，WST

  Baseline (before treatment), 3 days after treatment

• degree of swallowing difficulty，GUSS

  Baseline (before treatment), 3 days after treatment

• length of stay

  at discharge

Other Outcomes (1)

• the incidence rate of pneumonia

  30 days after extubation

Study Arms (2)

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

Interventions

No intervention OTHER

No intervention methods

Swallowing training plus No intervention

Swallowing training BEHAVIORAL

Swallowing training includes facial function training, sensory stimulation training, and airway protection techniques.

Swallowing training plus No intervention; a bilateral high-frequency repetitive transcranial magnetic stimulation plus swallowing training

a bilateral high-frequency repetitive transcranial magnetic stimulation DEVICE

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.

a bilateral high-frequency repetitive transcranial magnetic stimulation plus swallowing training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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);

Sponsors & Collaborators

• Wuhan University: lead

Study Sites (1)

Zhongnan hospital of Wuhan University, Wuhan, Hubei 430070

Wuhan, Hubei, 430070, China

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding After the intervention allocation, the participants and data analysts will be blinded. This is a single - blinded, randomized, parallel - controlled study focusing on rTMS. In the rTMS group, a 20 - minute magnetic stimulation will be applied to the target brain area.. Before the final code - breaking, data analysts won't know the group to which the data they are analyzing belongs.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: February 2, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

CN (1)