Clinical trial NCT04198207: The Effectiveness and Safety of Vagus Nerve Stimulation for TRE
Official title: Clinical Evaluation of the Effectiveness and Safety of Vagus Nerve Stimulation for Tuberous Sclerosis Complex Related Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberous Sclerosis Complex
Epilepsy
Keywords: tuberous sclerosis complex
epilepsy
vagus nerve stimulation
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: The First Hospital of Jilin University
name: Xuanwu Hospital, Beijing
name: Capital Medical University
name: Peking University First Hospital
name: China-Japan Friendship Hospital
name: Chinese PLA General Hospital
name: Fourth Medical Center of PLA General Hospital
name: Capital Institute of Pediatrics, China
name: The Second Hospital of Hebei Medical University
name: Xijing Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: Children's Hospital of Fudan University
name: RenJi Hospital
name: Jining Medical University
name: Xiamen Humanity Hospital
name: Xiangya Hospital of Central South University
name: Wuhan Medical Care Center for Women and Children
name: Guangdong 999 Brain Hospital
name: Shenzhen Children's Hospital
name: Army Medical University, China
name: West China Hospital
First posted: 2019-12-13
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from multiple epilepsy centers in China

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.

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.

Primary outcomes:
measure: % of patients with Mchugh grading
timeFrame: 4 years
Secondary outcomes:
measure: IQ
timeFrame: 3 years
measure: Quality of Life: QOLIE-31
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children's Hospital
Study officials:
References: