The Efficacy and Safety of Subiculum Electrical Stimulation for Temporal Lobe Epilepsy With Bilateral Hippocampal Sclerosis: A Prospective, Single-Arm Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of Subiculum as adjunctive therapy for reducing the frequency of seizures in drug-resistant temporal lobe epilepsy with bilateral hippocampal sclerosis

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 65
Healthy Volunteers: f
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• Participants are between the ages of 14 -65 years of age

• Refractory to anti-seizure medications (ASMs).

• Persistence of disabling seizures at least 3 times per 3 months or greater, and once or more in recent 1 month.

• After comprehensive preoperative evaluation, patients who are considered unsuitable for or refuse resection surgery, or those for whom the effects of epileptic focus resection and thermocoagulation surgery are not satisfactory.

• Participants must have had a non-invasive video-EEG monitoring revealing seizure semiology and ictal EEG consistent with bilateral Temporal Lobe Epilepsy

• Biliteral hippocampal atrophy on MRI T1 imaging with increased ipsilateral mesial signal on T2 imaging

• Informed consent signed.

Locations
Other Locations
China
Xuanwu Hospital,Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Liankun Ren, MD
renlk2022@outlook.com
+86 13681576621
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 6
Treatments
Experimental: subiculum-DBS group
participants will undergo subiculum-DBS ON with the individual stimulation parameters determined in the parameter determination period, then continue to receive stimulation for the remainder of the study.
Sponsors
Leads: Xuanwu Hospital, Beijing

This content was sourced from clinicaltrials.gov