The Effectiveness and Safety of Vagus Nerve Stimulation for TRE

Clinical Evaluation of the Effectiveness and Safety of Vagus Nerve Stimulation for Tuberous Sclerosis Complex Related Epilepsy

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

Study Overview

• Status: Completed
• Conditions: Epilepsy; Tuberous Sclerosis Complex

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 Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients from multiple epilepsy centers in China

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
VNS Group; VNS group: 20 patients with no localilzed epileptogenic tuber in the brain, and with VNS and multiple anti-seizure medicines.
Control Group; Control group: 50 patients with no localilzed epileptogenic tuber in the brain, and with multiple anti-seizure medicines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% of patients with Mchugh grading	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.	4 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beijing Children's Hospital
• Collaborators: Peking University First Hospital; Xijing Hospital; Xiangya Hospital of Central South University; Beijing Tiantan Hospital; Chinese PLA General Hospital; The Second Hospital of Hebei Medical University; RenJi Hospital; West China Hospital; First Affiliated Hospital Xi'an Jiaotong University; Xuanwu Hospital, Beijing; Children's Hospital of Fudan University; China-Japan Friendship Hospital; The First Hospital of Jilin University; Capital Medical University; Jining Medical University; Shenzhen Children's Hospital; Guangdong 999 Brain Hospital; Fourth Medical Center of PLA General Hospital; Capital Institute of Pediatrics, China; Xiamen Humanity Hospital; Wuhan Medical Care Center for Women and Children; Xinqiao Hospital, Army Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Actual): December 10, 2024
• Study Completion (Actual): December 10, 2024

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: epilepsy; vagus nerve stimulation; tuberous sclerosis complex
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Neoplasms; Genetic Diseases, Inborn; Neurodegenerative Diseases; Congenital Abnormalities; Heredodegenerative Disorders, Nervous System; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Hamartoma; Neoplasms, Multiple Primary; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Sclerosis; Tuberous Sclerosis; Epilepsy
• Other Study ID Numbers: TRE-VNS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No