Clinical Trial of MgLiTT for Medical Refractory Epilepsy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Epilepsy

Intervention / Treatment
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* Device: Sinovation Laser Ablation System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thermal ablation, Stereotactic surgery, Medical refractory epilepsy, Epilepsy surgery