Clinical Trial of MgLiTT for Medical Refractory Epilepsy
- Conditions
- Epilepsy
- Interventions
- Device: Sinovation Laser Ablation System
- Registration Number
- NCT04569071
- Lead Sponsor
- Beijing Tiantan Hospital
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 110
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sinovation Laser Ablation System treatment Sinovation Laser Ablation System Sinovation Laser Ablation System treatment
- Primary Outcome Measures
Name Time Method MgLiTT ablation rate Within 3 days after operation Measurement of postsurgical MRI
- Secondary Outcome Measures
Name Time Method Seizure free rate 90±7 days after operation Follow-up
Seizure reduction rate 90±7 days after operation Follow up
Operation time Within 1 day after operation Medical recording
Postsurgical hospitalization Within 1 day after discharged from hospital Medical recording
Mini-Mental State Examination (MMSE) score Before and 90±7 days after operation Range from 0 to 30; Lower score indicates worse cognitive impairment
Quality of life in epilepsy-31 inventory (QOLIE-31) score Before and 90±7 days after operation For adult; Range from 0 to 100; Higher score indicates better quality of life
Quality of life in epilepsy for Adolescents (QOLIE-AD-48) score Before and 90±7 days after operation For Adolescents; Range from 0 to 100; Higher score indicates better quality of life
Vital signs-body temperature Before and 2±1 days after operation From medical recording; Centigrade
Vital signs-pulse Before and 2±1 days after operation From medical recording; Times/minute
Vital signs-respiratory rate Before and 2±1 days after operation From medical recording; Times/minute
Vital signs-blood pressure Before and 2±1 days after operation From medical recording; Systolic pressure/diastolic pressure (mmHg)
Trial Locations
- Locations (1)
Beijing Tiantan Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China