The Effectiveness and Safety of Resective Epilepsy Surgery for TRE

Active, not recruiting

• Conditions: Epilepsy; Tuberous Sclerosis Complex

• Registration Number: NCT04198181
• Lead Sponsor: Beijing Children's Hospital

Brief 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.

Detailed Description

Two hundred candidates are recruited and assigned to the control and surgery groups with 100 cases in each group, respectively. All patients will accept first-stage pre-enrollment evaluations and patients in surgery group will accept second-stage invasive evaluation.

All patients will be advised to visit the hospitals for examination each year after enrollment. Seizure outcomes will be assessed with reference to patients' seizure diaries and caregivers' oral statements by both neurosurgeons and neurologists.

All adverse effects will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 (2017).

Statistical analyses were conducted using SPSS (version 26.0, IBM, USA), Stata (version 16.0, Stata Corp LLC, USA), and R (version 4.3.3, R Foundation for Statistical Computing, Austria). Outcomes were presented according to data type as percentages, mean ± standard deviation, or median (interquartile range, IQR).

Multiple imputation was employed to address missing data for IQ and QOL at enrollment and the 2-year follow-up. A sensitivity analysis was conducted to assess the robustness of the multiple imputation results. The "mi impute regress" statement in Stata facilitated the multiple imputations. 20 T-tests were utilized for comparing continuous variables, with results reported as mean ± standard deviation. The Mann-Whitney U test was applied for non-normally distributed continuous variables, presenting results as median values and IQRs. Chi-square and Fisher's exact tests were used for univariate analyses. A significance level of p \< 0.05 was established.

To account for differences in covariates between the surgery and medicine groups, propensity score matching (PSM) was performed. Based on PSM, Kaplan-Meier curves and the log-rank test were utilized to analyze time-to-seizure recurrence differences between the surgery and medicine groups. Additionally, multivariable Cox proportional hazards regression was applied to predict risk factors for postoperative seizure recurrence within a 51-month follow-up period after PSM.

Study Timeline

• Study First Submitted: 2019-12-09
• Study Start: 2019-12-12
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-13
• Status Verified: 2024-05
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-17
• Primary Completion: 2027-03-15
• Study Completion: 2027-03-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
% of patients with ILAE grading	3 years	The grading made by ILAE for the classification of outcome with respect to epileptic seizures following epilepsy surgery. It contains a total of 6 levels. The higher the level, the worse the result. We will count the percentage of patients at each level.

Secondary Outcome Measures

Name	Time	Method
IQ	3 years	Wechsler Preschool and Primary Scale of Intelligence（WPPSI-III），Wechsler Intelligence Scale for Children (WISC-IV) and Wechsler Adult Intelligence Scale (WAIS-IV)，3 scales will be used for different ages to measure IQ. Higher scores mean better outcomes.
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.

Trial Locations

Locations (1)

Beijing Children's Hospital; 🇨🇳 Beijing, Beijing, China