Epilepsy, Tuberous Sclerosis Complex
Conditions
Keywords
tuberous sclerosis complex, epilepsy, vagus nerve stimulation
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.
Interventions
None listed
Sponsors
Beijing Tiantan Hospital
The First Bethune Hospital of Jilin University
Xuanwu Hospital, Beijing
Capital Medical University
Peking University First Hospital
China-Japan Friendship Hospital
Chinese PLA General Hospital
Fourth Medical Center of PLA General Hospital
Capital Institute of Pediatrics, China
The Second Hospital of Hebei Medical University
Xijing Hospital
First Affiliated Hospital Xi'an Jiaotong University
Children's Hospital of Fudan University
RenJi Hospital
Jining Medical University
Xiamen Humanity Hospital
Xiangya Hospital of Central South University
Wuhan Medical Care Center for Women and Children
Guangdong 999 Brain Hospital
Shenzhen Children's Hospital
Army Medical University, China
West China Hospital
Beijing Children's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed