Clinical Evaluation of the Effectiveness and Safety of Vagus Nerve Stimulation for Tuberous Sclerosis Complex Related Epilepsy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tuberous Sclerosis Complex
- Sponsor
- Beijing Children's Hospital
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- % of patients with Mchugh grading
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Shuli Liang
Director of Functional Neurosurgery
Beijing Children's Hospital
Eligibility 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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
% of patients with Mchugh grading
Time Frame: 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 Outcomes
- IQ(3 years)
- Quality of Life: QOLIE-31(3 years)