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Study on the effectiveness and mechanism of auricular vagus nerve modulation in improving drug-resistant epilepsy

Study on the effectiveness and mechanism of auricular vagus nerve modulation in improving drug-resistant epilepsy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118936
Enrollment
Unknown
Registered
2026-02-12
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

Drug-resistant epilepsy

Interventions

Single set:Auricular vagus nerve modulation

Sponsors

Second Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Subjects must meet all of the following conditions: (1) Clearly having drug-resistant epilepsy and requiring routine SEEG treatment; Criteria for drug-resistant epilepsy: After taking two or more antiepileptic drugs on schedule, at sufficient doses, and with blood concentrations within the effective range, epilepsy seizures cannot be effectively controlled after regular, systematic treatment for at least 12 months, with daily seizures or an average of 1-2 seizures per month; (2) Having normal communication abilities; (3) Age range: 18-60 years, gender unrestricted; (4) Not having received similar neuromodulation training.

Exclusion criteria

Exclusion criteria: (1) Unable to cooperate with the test; (2) Previously undergone cranial surgery or intracranial electrode implantation; (3) Have other comorbidities and have already received or require implantation of a pacemaker, defibrillator, or cochlear implant; (4) Medication use: currently taking drugs that may affect central nervous system function; (5) Skin issues: have skin infections, wounds, or other skin problems in the area of contact with the neuromodulation device; (6) Psychological dependence: history of drug abuse or alcohol dependence.

Design outcomes

Primary

MeasureTime frame
Changes in seizure frequency and the functional connectivity strength between the epileptic focus and the default mode network in epilepsy patients after one week of continuous taVNS intervention;

Secondary

MeasureTime frame
The difference between the reaction time and accuracy of memory tests in epilepsy patients on the day of the first taVNS intervention compared with baseline;Difference in functional connectivity strength between the patient's epileptic focus and the default mode network on the day of the first taVNS intervention compared to baseline;After one week of continuous taVNS intervention, the difference in reaction time and accuracy of memory tests in epilepsy patients compared with baseline;Half a month after the end of taVNS intervention, the difference in seizure frequency in epilepsy patients compared to baseline;Half a month after taVNS intervention, the reaction time and accuracy of memory tests in epilepsy patients were different from baseline;Half a month after the end of taVNS intervention, the difference in functional connectivity strength between the patient's epileptic focus and the default mode network compared to baseline;

Countries

China

Contacts

Public ContactYang Hui

Second Affiliated Hospital of Army Medical University

18908390069@163.com+86 138 0839 0069

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026