Extreme Capsule Electrical Stimulation for Drug-resistant Focal Epilepsy

NCT06663124 | Not Yet Recruiting

• 1 other identifier: 2023-083
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Epilepsy, Drug Resistant

Keywords

Extreme capsule; Deep Brain Stimulation; Drug Resistant Epilepsy; Focal Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Seizure Responder Rate

  Up to 1 year after EC-DBS

• Life quality evaluation

  Up to 1 year after EC-DBS

• Adverse Events

  Up to 1 year after EC-DBS

• Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)

  Up to 1 year after EC-DBS

Study Arms (1)

EC-DBS group

EXPERIMENTAL

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

Interventions

EC-DBS ON DEVICE

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.

EC-DBS group

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital,Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy; Epilepsies, Partial

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Liankun Ren, MD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liankun Ren, MD

CONTACT

+86 13681576621; renlk2022@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 27, 2024
• First Posted: October 29, 2024
• Study Start: November 1, 2024
• Primary Completion: January 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)