🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT04198181
Active, not recruiting Observational

The Effectiveness and Safety of Resective Epilepsy Surgery for TRE

NCT04198181 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Children's Hospital
Phase
Observational
Started
2019-12-12
Last updated
2025-01-17

Condition(s) studied

Tuberous Sclerosis ComplexEpilepsy

Investigational drug(s) / intervention(s)

Surgery

Surgery: Resective surgery included lobectomy (partial or total brain lobe resection), tuberectomy (epileptogenic tuber resection), and tuberectomy plus (resection of epileptogenic tuber and perituberal gyri). Tuberectomy was typically performed on the epileptogenic tuber within or near an eloquent area. Lobectomy was performed in patients with large epileptogenic tubers in the brain lobes. Multiple lobectomies, tuberectomies, tuberectomies plus, and lobectomy combined with tuberectomy/tuberectomies plus were further performed in patients with multiple epileptogenic tubers.

Study summary

A prospective cohort studies to identify clinical seizure control, cognitive changes, and safety in resective epilepsy surgery in patients with TSC-related drug-resistant epilepsy.

Eligibility

Sex
ALL
Min age
2 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 2 years old and above, no gender restriction, TSC gene monitoring with or without abnormality * Diagnosis of tuberous sclerosis- related drug-resistant epilepsy * Epilepsy course for more than 1 year * Patients who have taken 3 or more reasonable choices with appropriate and tolerable antiepileptic drugs (excluding mTOR inhibitors and traditional Chinese medicine and prescriptions) had seizures more than 12 times in the 3 months before enrollment * The family members agreed to enroll and signed the informed consent. Exclusion Criteria: * Obvious renal angiomyolipoma, pulmonary lymphoma leiomyomatosis, and subventricular giant cell astrocytoma * Abnormal heart, lung, liver, and kidney functions and coagulation function * Preoperative evaluation, it is considered that no surgical treatment is needed * The patient received other craniocerebral surgical treatment within 1 year during the follow-up period

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Beijing Children's Hospital Beijing Beijing Municipality

More Beijing Children's Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04198181 on ClinicalTrials.gov ↗ ← All trials in China