An observational study in Tuberous Sclerosis Complex and Epilepsy, sponsored by Beijing Children's Hospital. Completed at 1 site in China. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2024-12-19.
Sponsored by Beijing Children's Hospital · Observational
Prospective cohort studies to identify clinical epilepsy control, cognitive changes, and safety of VNS in patients with tuberous sclerosis complex-related epilepsy.
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.
109 studies on the registry are indexed under Tuberous Sclerosis; 27 are open to participants now.
This study's enrollment of 70 is below the median of 158 across 36 observational studies indexed under Tuberous Sclerosis.
Browse Tuberous Sclerosis studies →Beijing Children's Hospital is the lead sponsor of 51 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients from multiple epilepsy centers in China
Exclusion Criteria：
VNS group: 20 patients with no localilzed epileptogenic tuber in the brain, and with VNS and multiple anti-seizure medicines.
Control group: 50 patients with no localilzed epileptogenic tuber in the brain, and with multiple anti-seizure medicines.
% 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.
Time frame: 4 years
IQ
Wechsler Intelligence Scale is used for the evaluation of IQ
Time frame: 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.
Time frame: 3 years
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Beijing Children's Hospital