Clinical Trial of MgLiTT for Medical Refractory Epilepsy

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04569071
• Other study ID #: HK593202002
• Status: Recruiting
• Phase: N/A
• Start date: August 8, 2020
• Est. completion date: February 8, 2022

Study information

• Verified date: September 2020
• Source: Beijing Tiantan Hospital
• Contact: Kai Zhang, Dr.
• Phone: +86 13501196619
• Email: zhangkai62035[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: February 8, 2022
• Est. primary completion date: May 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy

Intervention

Device:
• Sinovation Laser Ablation System
In the present single arm study. All eligible subjects will undergo MgLiTT with the Sinovation Laser Ablation System.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Chinese PLA General Hospital, Peking Union Medical College Hospital, Peking University International Hospital, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Instrument performance evaluation	Higher score indicates better instrument performance	Within 1 day after operation
Other	The amount of bleeding	Medical recording	During operation
Other	Postsurgical complication rates	Medical recording	Within 1 day after discharged from hospital
Other	Failure free rate of laser ablation minimally invasive treatment kit	Medical recording	Within 1 day after operation
Other	Failure rate of magnetic resonance guided laser ablation system	Medical recording	Within 1 day after operation
Other	Incidence of adverse events and serious adverse events	Medical recording	Within 1 day after discharged from hospital
Primary	MgLiTT ablation rate	Measurement of postsurgical MRI	Within 3 days after operation
Secondary	Seizure free rate	Follow-up	90±7 days after operation
Secondary	Seizure reduction rate	Follow up	90±7 days after operation
Secondary	Operation time	Medical recording	Within 1 day after operation
Secondary	Postsurgical hospitalization	Medical recording	Within 1 day after discharged from hospital
Secondary	Mini-Mental State Examination (MMSE) score	Range from 0 to 30; Lower score indicates worse cognitive impairment	Before and 90±7 days after operation
Secondary	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
Secondary	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
Secondary	Vital signs-body temperature	From medical recording; Centigrade	Before and 2±1 days after operation
Secondary	Vital signs-pulse	From medical recording; Times/minute	Before and 2±1 days after operation
Secondary	Vital signs-respiratory rate	From medical recording; Times/minute	Before and 2±1 days after operation
Secondary	Vital signs-blood pressure	From medical recording; Systolic pressure/diastolic pressure (mmHg)	Before and 2±1 days after operation