Extreme Capsule Electrical Stimulation for Drug-resistant Focal Epilepsy

Not Applicable

Not yet recruiting

• Conditions: Epilepsy, Drug Resistant

• Registration Number: NCT06663124
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

Evaluation of the Efficacy and Safety of Deep Brain Stimulation of the Extreme Capsule (EC) for the Treatment of Drug-Resistant Epilepsy

Detailed Description

This studyTo evaluate the efficacy and safety of deep brain stimulation of the EC for the treatment of drug-resistant epilepsy originating from EC structurally connected cortex cortex, This study aims to explore stimulation patterns and parameters that can suppress abnormal epileptic discharges at the seizure focus without impairing language function. This study aims to improve treatment challenges for these patients and promote clinical translation and application

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-27
• Study First Submitted QC: 2024-10-27
• Last Update Submitted: 2024-10-27
• Study First Posted: 2024-10-29
• Last Update Posted: 2024-10-29
• Study Start: 2024-11-01
• Primary Completion: 2025-01-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Participants are between the ages of 14 -65 years of age
• Diagnosis of drug-resistant epilepsy follows the standard of resistance to regular medication treatment for at least two years. Comprehensive preoperative epilepsy assessment, combined with individualized fiber tracking, is used to determine whether the epileptogenic zone is located in cortex regions structurally connected to the extreme capsule.
• Persistence of disabling seizures at least 3 times per month or greater,
• Informed consent signed.

Exclusion Criteria

• Structural alterations are present in the extreme capsule.
• Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations;
• Psychogenic non-epileptic seizures within 12 months;
• Presence of implanted electrical stimulation medical device anywhere in the body (e.g., pacemaker, spinal cord stimulator, responsive neurostimulation) or any metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagal nerve stimulators are allowed if the parameter remains stable for at least 3 months prior to the screening visit;
• Risk factors that would put the participant at risk for intraoperative or postoperative bleeding. (e.g., coagulation abnormalities, etc.) or the need for chronic anticoagulation or antiplatelet aggregation medications;
• IQ < 55 or severe cognitive dysfunction, unable to complete the study;
• Diagnosed with a progressive neurological disorder (including progressive Rasmussen's encephalitis, etc.);
• Diagnosed with a severe neuropsychiatric disorder such as dementia, major depression (admission to a psychiatric specialty/hospital within 5 years or any suicidal or self-injurious tendencies), schizophrenia, or neurodegenerative disorders;
• Diagnosed with other serious physical disorders, internal diseases or severe abnormalities in liver or kidney function;
• Pregnant, or planning to pregnant within 2 years;
• Participation in another clinical study within 3 months;
• Not suitable for enrollment as assessed by the multidisciplinary team of the center.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Seizure frequency (SF28)	Up to 1 year after EC-DBS	Seizure frequency (SF28) is defined as seizure count per month (28-day) period. The SF28 is calculated as follows, where D=total number of days for which seizure information is collected for the specific 28-day interval: SF28=(Total number of seizures in D days/D)\*28. In addition, the baseline seizure frequency is defined as mean of 3-month SF28 in the baseline period. The seizure frequency in double-blind phase is defined as SF28 per month during the double-blind period. Percent change in seizure frequency=100\*(double-blind SF28-baseline SF28)/baseline SF28.

Secondary Outcome Measures

Name	Time	Method
Seizure Responder Rate	Up to 1 year after EC-DBS	The proportion of patients with a ≥ 50% reduction from Baseline in seizure frequency.
Life quality evaluation	Up to 1 year after EC-DBS	Percentage change from baseline in Quality of Life in Epilepsy-31 inventory (QOLIE-31) score.
Adverse Events	Up to 1 year after EC-DBS	Rate of adverse events which were judged to be study-related throughout the study.
Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)	Up to 1 year after EC-DBS	The number presented is for Definite and Probable SUDEP. The rate is calculated per 1000 subject years of follow

Trial Locations

Locations (1)

Xuanwu Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China