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

Prospective controlled studies to identify clinical epilepsy control, cognitive changes, and safety in resective epilepsy surgery of tuberculosis-related epilepsy.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy; Tuberous Sclerosis Complex

Detailed Description

Control group: clear epilepsy focus in the brain, and medication has been continued.

Surgery group: clear epilepsy focus in the brain, and resective epilepsy surgery for tuberculosis-related epilepsy.

In order to ensure the follow-up of the study and 3 years after the end of the study, 100 cases were collected from each group of the study.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Shuli Liang, doctor; Phone Number: 86-010-59617051; Email: 301_1sjwk@sina.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100045
      • Recruiting
      • Beijing Children's Hospital
      • Contact: Shuli Liang, doctor; Phone Number: 86-010-7051; Email: 301_1sjwk@sina.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients from participating medical institutions

Description

Inclusion Criteria:

• 2 years old and above, no gender restriction, TSC gene monitoring with or without abnormality
• Diagnosis of nodular sclerosis and 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
• The family did not sign the informed consent
• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% of patients with ILAE grading	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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years
IQ	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.	3 years

Collaborators and Investigators

• Sponsor: Beijing Children's Hospital
• Collaborators: Peking University First Hospital; Xijing Hospital; Xiangya Hospital of Central South University; Beijing Tiantan Hospital; Chinese PLA General Hospital; The Second Hospital of Hebei Medical University; RenJi Hospital; West China Hospital; First Affiliated Hospital Xi'an Jiaotong University; Xuanwu Hospital, Beijing; Children's Hospital of Fudan University; China-Japan Friendship Hospital; The First Hospital of Jilin University; Capital Medical University; Jining Medical University; Shenzhen Children's Hospital; Guangdong 999 Brain Hospital; Fourth Medical Center of PLA General Hospital; Capital Institute of Pediatrics, China; Xiamen Humanity Hospital; Wuhan Medical Care Center for Women and Children; Xinqiao Hospital, Army Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 12, 2019
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): February 1, 2024

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (ACTUAL): December 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 8, 2022
• Last Update Submitted That Met QC Criteria: March 6, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: epilepsy; tuberous sclerosis complex; resective epilepsy surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Congenital Abnormalities; Genetic Diseases, Inborn; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Neoplastic Syndromes, Hereditary; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Neurocutaneous Syndromes; Hamartoma; Neoplasms, Multiple Primary; Epilepsy; Sclerosis; Tuberous Sclerosis
• Other Study ID Numbers: TRE-RES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No