Research on improvement of swallowing function by swallowing motor activated vagus nerve stimulation: A single-center randomized, double-blind controlled clinical study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500096303

Enrollment

Unknown

Registered

2025-01-21

Start date

2024-04-01

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-stroke dysphagia

Interventions

Open-loop stimulation group:Transcutaneous auricular vagus nerve stimulation independent of swallowing training

Control group:Swallowing training and sham-stimulation

Closed-loop stimulation group:Transcutaneous auricular vagus nerve stimulation activated by swallowing training

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients diagnosed as stroke according to clinically qualified physicians, referring to the Chinese Stroke Prevention and Treatment Guidelines (2021); 2.Patients in the acute/convalescent phase (2 weeks after onset) with stable signs; 3.No previous neuropsychiatric disorder; 4.No obvious impairment of cognitive function, able to cooperate with the corresponding rehabilitation training; 5.With oropharyngeal dysphagia; 6.Water Swallow Test score =3 points; 7.Male or female, 18-80 years old; 8.Patients not receiving other neuroregulatory rehabilitation treatments; 9.No contraindication of ta-VNS or neuromuscular electrical stimulation; 10.Voluntarily participated in the study and signed informed consent;

Exclusion criteria

Exclusion criteria: 1. With other mental health disorders (dementia, Parkinson's disease, depression, schizophrenia, bipolar disorder, etc.); 2. With uncontrolled epilepsy, that is, seizures onset within 4 weeks prior to enrollment; 3. Arrhythmia or other abnormal conditions; 4. History of respiratory diseases or disorders, including dyspnea and asthma; 5. Difficulty in cooperation because of gastrointestinal diseases such as diarrhea and vomiting; 6. History of vasovagal syncope; 7. Receiving other neurostimulation/regulatory treatment; 8.Difficulty in communication and understanding, unable to cooperate with the completion of the experiment; 9.Pregnant and nursing women;

Design outcomes

Primary

Measure	Time frame
Change of MASA score;	—

Secondary

Measure	Time frame
Change of GUSS score;Change of fNIRS feature;Change of FCM score;	—

Countries

China

Contacts

Public ContactJunfa Wu

Huashan Hospital, Fudan University

3020@huashan.org.cn+86 135 8588 8698

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026