Extreme Capsule Electrical Stimulation for Drug-resistant Focal Epilepsy

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

Study Overview

• Status: Not yet recruiting
• Conditions: Epilepsy, Drug Resistant
• Intervention / Treatment: Device: EC-DBS ON

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liankun Ren, MD; Phone Number: +86 13681576621; Email: renlk2022@outlook.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital,Capital Medical University
      • Contact: Liankun Ren, MD; Phone Number: +86 13681576621; Email: renlk2022@outlook.com
      • Principal Investigator: Liankun Ren

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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: EC-DBS group; participants will undergo EC-DBS ON with the individual stimulation parameters determined in the parameter determination period, then continue to receive stimulation for the remainder of the study.

Device: EC-DBS ON; The surgical intervention named deep brain stimulation is a well-established neurosurgical treatment for drug-resistant epilepsy.The targets used in this study are extreme capsule.The devices used for intervention have been approved by Chinese National Medical Products Administration (CFDA). The postoperative drug dosage adjustment depends on the efficacy of DBS and the judgment of the epilepsy specialist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure frequency (SF28)	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.	Up to 1 year after EC-DBS

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Investigators: Principal Investigator: Liankun Ren, MD, Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: October 27, 2024
• First Submitted That Met QC Criteria: October 27, 2024
• First Posted (Actual): October 29, 2024

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 27, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Deep Brain Stimulation; Focal Epilepsy; Drug Resistant Epilepsy; Extreme capsule
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Drug Resistant Epilepsy; Epilepsy; Epilepsies, Partial
• Other Study ID Numbers: 2023-083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No