Clinical trial · Observational
The Effectiveness and Safety of Resective Epilepsy Surgery for TRE
Clinical Evaluation of the Effectiveness and Safety of Resective Epilepsy Surgery for Tuberous Sclerosis Complex Related Epilepsy
NCT04198181CI-TRIAL-00084806active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epilepsy | — | UNRESOLVED | — |
| Tuberous Sclerosis Complex | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Control Group
- description
- Patients in the surgery group will accept exclusive rational medicine therapy.
- label
- Surgery Group
- description
- Patients in the surgery group will undergo resective surgery combined with rational medicine therapy.
- interventionNames
- Procedure: Surgery
Primary outcomes (1)
- measure
- % of patients with ILAE grading
- timeFrame
- 3 years
- description
- 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 outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDWei Z, Liu T, Cao D, Zhang K, Yang Z, Guo Q, Xu J, Liu S, Liu X, Guan Y, Peng Y, Yuan L, Chen L, Peng J, Han X, Chen C, Chen F, Lin W, Yu T, Zhao X, Wang J, Zhao R, Kuang S, Shi X, Zhai F, Zhang S, Feng W, Shan Y, Ding P, Qian R, Fang F, Chen S, Li H, Wang Y, Liu Q, Zhang H, Li W, Sun M, Zhang R, Liang S. Resective Surgery for Drug-Resistant Epilepsy in Patients With Tuberous Sclerosis Complex: A Prospective Nationwide Multicenter Cohort Study. Neurology. 2025 Nov 11;105(9):e214260. doi: 10.1212/WNL.0000000000214260. Epub 2025 Oct 16. PMID 41100778