Clinical trial NCT06663124: Extreme Capsule Electrical Stimulation for Drug-resistant Focal Epilepsy
Official title: Extreme Capsule Electrical Stimulation for Drug-resistant Focal Epilepsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epilepsy, Drug Resistant
Keywords: Extreme capsule
Deep Brain Stimulation
Drug Resistant Epilepsy
Focal Epilepsy
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 10
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Seizure frequency (SF28)
timeFrame: Up to 1 year after EC-DBS
Secondary outcomes:
measure: Seizure Responder Rate
timeFrame: Up to 1 year after EC-DBS
measure: Life quality evaluation
timeFrame: Up to 1 year after EC-DBS
measure: Adverse Events
timeFrame: Up to 1 year after EC-DBS
measure: Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)
timeFrame: Up to 1 year after EC-DBS
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital,Capital Medical University
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Liankun Ren, MD
role: PRINCIPAL_INVESTIGATOR
References: