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Optimizing the stimulation intensity of transcutaneous auricular vagus nerve stimulation in patients with prolonged disorders of consciousness

Optimizing the stimulation intensity of transcutaneous auricular vagus nerve stimulation in patients with prolonged disorders of consciousness

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113359
Enrollment
Unknown
Registered
2025-11-27
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

prolonged disorders of consciousness

Interventions

Control group:Routine rehabilitation
Low intensity intervention group :Low intensity transcutaneous auricular vagus nerve stimulation
Moderate intensity intervention group :Moderate intensity transcutaneous auricular vagus nerve stimulation
High Intensity Intervention Group :High Intensity transcutaneous auricular vagus nerve stimulation

Sponsors

Zhangzhou Affiliated Hospital of Fujian medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 65 years; 2. Patients with brain injury of known aetiology; 3. Diagnosed with vegetative state/minimally conscious state (based on CRS-R assessment over five consecutive days); 4. Disease duration exceeding 28 days; 5. Skin at the stimulation site intact and free from lesions; 6. Informed consent obtained.

Exclusion criteria

Exclusion criteria: 1. Patients with unstable vital signs; 2. Patients with active intracranial hypertension; 3. Patients with implanted cardiac pacemakers, cochlear implants, or intracranial metallic implants; 4. Patients with a history of central nervous system disorders; 5. Patients undergoing deep sedation due to general anaesthesia or central nervous system depressants; 6. Patients with bradycardia, atrial fibrillation, or atrioventricular block; 7. Pregnant patients.

Design outcomes

Primary

MeasureTime frame
Coma Recovery Scale-Revised;functional connectivity strength;

Secondary

MeasureTime frame
Glasgow Coma Scale;Glasgow Outcome Scale;

Countries

China

Contacts

Public ContactHaoqing Jiang

Zhangzhou Hospital Affiliated to Fujian Medical University

jhq198287@163.com+86 150 8058 7205

Outcome results

None listed

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