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The Effectiveness and Safety of Vagus Nerve Stimulation for TRE

NCT04198207

CompletedN/A

Sponsor: Beijing Children's Hospital

Conditions: Tuberous Sclerosis Complex, Epilepsy

Countries: China

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

Eligibility overview

Sex: ALL

Age: 1 Year to 18 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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.
* Pregnancy or Lactation: Pregnant or breastfeeding individuals.
* Poor Compliance: Inability to adhere to follow-up visits or treatment protocols.

Locations (1)

Beijing, China