The Effectiveness and Safety of Resective Epilepsy Surgery for TRE

Sponsor

Beijing Children's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04198181

Collaborator

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

200

Enrollment

Location

49.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Tuberous Sclerosis Complex Epilepsy

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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Clinical Evaluation of the Effectiveness and Safety of Resective Epilepsy Surgery for Tuberous Sclerosis Complex Related Epilepsy

Actual Study Start Date :

Dec 12, 2019

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Outcome Measures

Primary Outcome Measures

% 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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Children's Hospital	Beijing	Beijing	China	100045

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shuli Liang, Director of Functional Neurosurgery, Beijing Children's Hospital

ClinicalTrials.gov Identifier:

NCT04198181

Other Study ID Numbers:

TRE-RES

First Posted:

Dec 13, 2019

Last Update Posted:

Mar 8, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Shuli Liang, Director of Functional Neurosurgery, Beijing Children's Hospital

tuberous sclerosis complex

epilepsy

resective epilepsy surgery

Additional relevant MeSH terms:

Tuberous Sclerosis

Epilepsy

Sclerosis

Study Results

No Results Posted as of Mar 8, 2022