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Transcutaneous auricular vagus nerve stimulation with conventional swallowing rehabilitation training for recovery of swallowing function and Its neural mechanismsin in patients with stroke

Transcutaneous auricular vagus nerve stimulation with conventional swallowing rehabilitation training for recovery of swallowing function and Its neural mechanismsin in patients with stroke

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110212
Enrollment
Unknown
Registered
2025-10-10
Start date
2025-10-15
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Stroke

Interventions

Treatment Group(patients):Transcutaneous auricular vagus nerve stimulation (taVNS) was administered synchronously during 30-minute conventional swallowing rehabilitation training in stroke patients.
Control Group(patients):The sham stimulation uses a subthreshold stimulation intensity.
Intervention Group(healthy individuals):Transcutaneous auricular vagus nerve stimulation (taVNS) was administered simultaneously with 30 minutes of swallowing-related exercises in healthy individuals.

Sponsors

Department of Rehabilitation Medicine, Sir Run Run Hospital, Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients:1.First onset of unilateral supratentorial cerebral infarction or cerebral hemorrhage, confirmed by CT or MRI;2. Aged between 18 and 80 years;3.Within one week to six months after onset;4. A Water Swallow Test score >= 3;5. Montreal Cognitive Assessment (MoCA) score > 18. Healthy individuals: 1. Aged 18 and above, all genders; 2.Without significant cognitive impairments or severe neurological disorders that may affect study outcomes.

Exclusion criteria

Exclusion criteria: 1. Implanted electronic devices (e.g., cardiac pacemakers); 2. Dysphagia caused by other neurological disorders such as Parkinson’s disease or multiple sclerosis; 3. History of vagotomy or vagus nerve injury; structural diseases of the esophagus or larynx; 4. Skin conditions that may interfere with stimulation or device placement, including scar tissue, skin lesions, or active diseases of the auricle and external auditory canal; 5. Severe cardiac, pulmonary, or hepatic dysfunction; 6. Resting heart rate < 60 beats per minute.

Design outcomes

Primary

MeasureTime frame
Task-related HbO2 concentration changes (changes in cerebral blood flow).;Heart rate variability;Motor-evoked potentials, MEP;A Water Swallow Test;Modified Mann Assessment of Swallowing(MASA);Standardized Swallowing Assessment(SSA);Swallowing Quality of life;surface electromyography;

Secondary

MeasureTime frame
Functional Oral Intake Scale;Montreal Cognitive Assessment;Modified Barthel Index;Fatigue Severity Scale;swallowing sound;

Countries

China

Contacts

Public ContactZhongli Jiang

Department of Rehabilitation Medicine, Sir Run Run Hospital, Nanjing Medical University

jiangzhongli@njmu.edu.cn+86 138 5189 8370

Outcome results

None listed

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