The Effectiveness and Safety of Vagus Nerve Stimulation for TRE

Completed

• Conditions: Epilepsy; Tuberous Sclerosis Complex

• Registration Number: NCT04198207
• Lead Sponsor: Beijing Children's Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2019-12-09
• Study Start: 2019-12-10
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-13
• Status Verified: 2024-12
• Primary Completion: 2024-12-10
• Study Completion: 2024-12-10
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
% of patients with Mchugh grading	4 years	The grading made by Mchugh for the classification of outcome with respect to epileptic seizures following epilepsy surgery. It contains a total of 5 levels. The higher the level, the worse the result. We will count the percentage of patients at each level.epileptic seizures following epilepsy surgery. It is used for assessing the control of epilepsy.

Secondary Outcome Measures

Name	Time	Method
IQ	3 years	Wechsler Intelligence Scale is used for the evaluation of IQ
Quality of Life: QOLIE-31	3 years	QOLIE-31 is suitable for patients 14 years and older. QOLCE-76 is applied to patients aged 2-13 by parents.

Trial Locations

Locations (1)

Beijing Children's Hospital; 🇨🇳 Beijing, China