Clinical Trial of MgLiTT for Medical Refractory Epilepsy

A Multi-center Clinical Trial to Evaluate the Efficacy and Safety of MRI-guided Laser Interstitial Thermal Therapy for Medical Refractory Epilepsy

Multicenter, open-label, prospective designed study to characterize the performance of MRI-guided laser interstitial thermal therapy (MgLiTT) using the Sinovation Laser Ablation System for the treatment of medical refractory epilepsy.

Study Overview

• Status: Unknown
• Conditions: Epilepsy
• Intervention / Treatment: Device: Sinovation Laser Ablation System

Detailed Description

The Sinovation Laser Ablation System uses robot-assisted, precise, high-intensity laser light to initiate necrosis of abnormal brain tissue through thermal ablation while limiting injury to adjacent healthy tissue. MgLiTT has the advantages of precision, minimal invasive procedure and real-time thermal monitoring.

Subjects who meet the study eligibility criteria and sign the informed consent form will undergo the MgLiTT procedure. Subjects, or their caregivers, are required to keep a seizure diary throughout the study, beginning after surgery. The study will monitor and record subjects' seizure frequency, antiepileptic medications, and physical and emotional health.

Subjects treated with Sinovation Laser Ablation System will have at least 9 months of follow-up. Throughout study participation, the study investigator will continuously monitor and document both effectiveness and safety data at study appointments.

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kai Zhang, Dr.; Phone Number: +86 13501196619; Email: zhangkai62035@sina.com
• Study Contact Backup: Name: Xiu Wang, Dr.; Phone Number: +86 13520908011; Email: wang19001@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Recruiting
      • Beijing Tiantan Hospital, Capital Medical University
      • Contact: Kai Zhang; Phone Number: +86 13501196619; Email: zhangkai62035@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The age ranged from 6 months to 70 years old;
• Previous diagnosis of drug-resistant epilepsy with focal lesions;
• The average seizure frequency was more than 2 times/month within 3 months;
• Surgical treatment is suitable for epilepsy;
• The subjects or their guardians can understand the purpose of the trial, show adequate compliance with the trial protocol, and sign the informed consent form.

Exclusion Criteria:

• MRI contraindication;
• Patients with severe coagulation dysfunction;
• Pregnant or lactating women;
• Subjects who have participated in clinical trials of any other drugs or medical devices within 3 months;
• Evidence of severe or uncontrollable systemic diseases, as judged by the researchers;
• Subjects considered unsuitable for the clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sinovation Laser Ablation System treatment	Device: Sinovation Laser Ablation System; In the present single arm study. All eligible subjects will undergo MgLiTT with the Sinovation Laser Ablation System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MgLiTT ablation rate	Measurement of postsurgical MRI	Within 3 days after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure free rate	Follow-up	90±7 days after operation
Seizure reduction rate	Follow up	90±7 days after operation
Operation time	Medical recording	Within 1 day after operation
Postsurgical hospitalization	Medical recording	Within 1 day after discharged from hospital
Mini-Mental State Examination (MMSE) score	Range from 0 to 30; Lower score indicates worse cognitive impairment	Before and 90±7 days after operation
Quality of life in epilepsy-31 inventory (QOLIE-31) score	For adult; Range from 0 to 100; Higher score indicates better quality of life	Before and 90±7 days after operation
Quality of life in epilepsy for Adolescents (QOLIE-AD-48) score	For Adolescents; Range from 0 to 100; Higher score indicates better quality of life	Before and 90±7 days after operation
Vital signs-body temperature	From medical recording; Centigrade	Before and 2±1 days after operation
Vital signs-pulse	From medical recording; Times/minute	Before and 2±1 days after operation
Vital signs-respiratory rate	From medical recording; Times/minute	Before and 2±1 days after operation
Vital signs-blood pressure	From medical recording; Systolic pressure/diastolic pressure (mmHg)	Before and 2±1 days after operation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Instrument performance evaluation	Higher score indicates better instrument performance	Within 1 day after operation
The amount of bleeding	Medical recording	During operation
Postsurgical complication rates	Medical recording	Within 1 day after discharged from hospital
Failure free rate of laser ablation minimally invasive treatment kit	Medical recording	Within 1 day after operation
Failure rate of magnetic resonance guided laser ablation system	Medical recording	Within 1 day after operation
Incidence of adverse events and serious adverse events	Medical recording	Within 1 day after discharged from hospital

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: Peking Union Medical College Hospital; Chinese PLA General Hospital; Xuanwu Hospital, Beijing; Peking University International Hospital
• Investigators: Study Director: Kai Zhang, Dr., Beijing TianTan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2020
• Primary Completion (Anticipated): May 8, 2021
• Study Completion (Anticipated): February 8, 2022

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 23, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Stereotactic surgery; Thermal ablation; Medical refractory epilepsy; Epilepsy surgery
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Drug Resistant Epilepsy
• Other Study ID Numbers: HK593202002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: We may only share clinical information (rather privacy information) in academic or other reasonable request.
• IPD Sharing Time Frame: After the clinical trials.
• IPD Sharing Access Criteria: reasonable requests.
• IPD Sharing Supporting Information Type: Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No