The Effectiveness and Safety of Vagus Nerve Stimulation for TRE

Capital Medical University

Status: Completed

Conditions: Tuberous Sclerosis Complex; Epilepsy

Study type: Observational

Funder types: Other

Identifiers

NCT04198207

TRE-VNS

Details and patient eligibility

About

Prospective cohort studies to identify clinical epilepsy control, cognitive changes, and safety of VNS in patients with tuberous sclerosis complex-related epilepsy.

Full description

This study aims to evaluate the efficacy and safety of vagus nerve stimulation (VNS) in the treatment of drug-resistant epilepsy in patients with Tuberous Sclerosis Complex (TSC) and compare it with traditional antiepileptic drug therapy. By assessing seizure frequency, severity, and improvements in quality of life, the study seeks to provide evidence-based guidance for clinical treatment strategies.

Enrollment: 70 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Age Range: Patients aged 1 to 18 years.
• Confirmed Diagnosis: Diagnosed with Tuberous Sclerosis Complex (TSC) according to established diagnostic criteria.
• Drug-Resistant Epilepsy: Ineffectiveness of at least two antiepileptic drugs (monotherapy or combination therapy).
• Informed Consent: Patients and their guardians understand the purpose of the study and voluntarily sign the informed consent form.

Exclusion Criteria：

• Other Severe Diseases: Presence of significant cardiovascular, respiratory, or other systemic diseases.
• Psychiatric Disorders: History or presence of severe psychiatric disorders (e.g., schizophrenia or major depressive disorder).
• Surgical Contraindications: Unsuitability for general anesthesia or factors affecting surgical safety.
• Drug Allergy: Known allergy to drugs used in the study.
• Implant Conflict: Presence of implanted medical devices that may interfere with VNS therapy.
• Pregnancy or Lactation: Pregnant or breastfeeding individuals.
• Poor Compliance: Inability to adhere to follow-up visits or treatment protocols.

Trial design

70 participants in 2 patient groups

VNS Group

Description:

VNS group: 20 patients with no localilzed epileptogenic tuber in the brain, and with VNS and multiple anti-seizure medicines.

Control Group

Description:

Control group: 50 patients with no localilzed epileptogenic tuber in the brain, and with multiple anti-seizure medicines.