The Effectiveness and Safety of Resective Epilepsy Surgery for TRE

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04198181
• Other study ID #: TRE-RES
• Status: Completed
• Start date: December 12, 2019
• Est. completion date: March 15, 2024

Study information

• Verified date: May 2024
• Source: Beijing Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 15, 2024
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

• 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

Related Conditions & MeSH terms

• Epilepsy
• Sclerosis
• Tuberous Sclerosis
• Tuberous Sclerosis Complex

Locations

Country	Name	City	State
China	Beijing Children's Hospital	Beijing	Beijing

Sponsors (21)

Lead Sponsor

Collaborator

Beijing Children's Hospital

Capital Medical University, First Affiliated Hospital Xi'an Jiaotong University, First Medical Center, PLA General Hospital, Fourth Medical Center, PLA General Hospital, Guangdong 999 Brain Hospital, Henan Provincial People's Hospital, Peking University People's Hospital, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shandong Provincial Hospital, Shanghai Children's Hospital, Shenzhen Children's Hospital, The Affiliated Brain Hospital of Nanjing Medical University, The First Affiliated Hospital of Shanxi Medical University, The First Affiliated Hospital of University of Science and Technology of China, The First Hospital of Jilin University, The Second Hospital of Hebei Medical University, West China Hospital, Xiangya Hospital of Central South University, Xinqiao Hospital, Amry Medical University, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% 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	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
Secondary	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