The Effectiveness and Safety of Vagus Nerve Stimulation for TRE

Epilepsy Clinical Trial

Official title:

Clinical Evaluation of the Effectiveness and Safety of Vagus Nerve Stimulation for Tuberous Sclerosis Complex Related Epilepsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04198207
• Other study ID #: TRE-VNS
• Status: Recruiting
• Start date: December 10, 2019
• Est. completion date: February 1, 2024

Study information

• Verified date: March 2022
• Source: Beijing Children's Hospital
• Contact: Shuli Liang, doctor
• Phone: 86-010-59617051
• Email: 301_1sjwk[@]sina.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

Control group: no clear epilepsy focus in the brain, and medication has been continued.

Surgery group: no clear epilepsy focus in the brain, and VNS for tuberculosis-related epilepsy.

In order to ensure the follow-up of the study and 3 years after the end of the study, 50 cases were collected in each group of the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 1, 2024
• Est. primary completion date: December 1, 2023
• 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

• 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

Related Conditions & MeSH terms

• Epilepsy
• Sclerosis
• Tuberous Sclerosis
• Tuberous Sclerosis Complex

Locations

Country	Name	City	State
China	Beijing Children's Hospital	Beijing

Sponsors (23)

Lead Sponsor

Collaborator

Beijing Children's Hospital

Beijing Tiantan Hospital, Capital Institute of Pediatrics, China, Children's Hospital of Fudan University, China-Japan Friendship Hospital, Chinese PLA General Hospital, First Affiliated Hospital Xi'an Jiaotong University, Fourth Medical Center of PLA General Hospital, Guangdong 999 Brain Hospital, Jining Medical University, Peking University First Hospital, RenJi Hospital, Sanbo Brain Hospital Capital Medical University, Shenzhen Children's Hospital, The First Hospital of Jilin University, The Second Hospital of Hebei Medical University, West China Hospital, Wuhan Medical Care Center for Women and Children, Xiamen Humanity Hospital, Xiangya Hospital of Central South University, Xijing Hospital, Xinqiao Hospital, Army 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.epileptic seizures following epilepsy surgery. It is used for assessing the control of epilepsy.	3 years
Secondary	IQ	Wechsler Intelligence Scale is used for the evaluation of IQ	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