Loading clinical trials...

High Selective Subiculum SEEG Guided RF-TC for mTLE-HS | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

High Selective Subiculum SEEG Guided RF-TC for mTLE-HS

The Efficacy and Safety of Subiculum Stereotactic-EEG Guided Radio-frequency Thermocoagulation for Mesial Temporal Lobe Epilepsy With Hippocampus Sclerosis: A Prospective, Single-Arm Trial

NCT06558864•Xuanwu Hospital, Beijing

View on ClinicalTrials.gov

Summary

The primary objective of this research is to study the efficacy and safety of Stereotactic EEG (SEEG) guided radio-frequency thermocoagulation (RF-TC) of Subiculum as adjunctive therapy for reducing the frequency of seizures in drug-resistant temporal lobe epilepsy with Mesial temporal lobe epilepsy with hippocampal sclerosis (mTLE-HS).

Detailed Description

Mesial temporal lobe epilepsy (mTLE) is the most classical subtype of temporal lobe epilepsy, which is the indication of surgical intervention after evaluation. This project aims to include 20 participants, and evaluate the effectiveness and safety of Stereotactic EEG (SEEG) guided radio-frequency thermocoagulation (RF-TC) of Subiculum in patients with mesial temporal lobe epilepsy with hippocampal sclerosis through A prospective, interventional, unblinded, single-arm clinical trial. It is expected to provide new therapeutic options for patients with mTLE-HS with alternative treatment options.

Eligibility

Age

14 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants are between the ages of 14 -65 years of age
•Refractory to anti-seizure medications (ASMs).
•Persistence of disabling seizures at least 2 times per month during the Baseline Phase，with no more than 30 days between seizures during the Baseline Phase.
•Hippocampal atrophy on MRI T1 imaging with increased ipsilateral mesial signal on T2 imaging
•Interictal EEG shows focal or lateralized spikes on temporal, frontal zone, or sphenoid electrode
•Ictal EEG onset is focal or lateralized on the ipsilateral side
•Ipsilateral temporal focal hypometabolism on PET
•Must be agreed by a consensus of ipsilateral mesial temporal origin by a multidisciplinary discussion

Exclusion Criteria

•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;
+1 more criteria

Key Dates

Start Date

August 9, 2024

Primary Completion Date

August 20, 2025

Completion Date

August 20, 2027

Last Updated

August 19, 2024

Enrollment

ESTIMATED participants

Conditions

Mesial Temporal Lobe Epilepsy With Hippocampal SclerosisEpilepsy

Interventions

Subiculum RF-TC

PROCEDURE

Contacts

Liankun Ren

CONTACT

+86 13681576621 renlk2022@outlook.com

Thalamus Seizure Detection With a Deep Brain Stimulator System

NCT06700356

Epilepsy; Seizure

View study

RECRUITINGPHASE1

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

NCT02531880

Epilepsy

View study

RECRUITINGNA

Intracranial Investigation of Neural Circuity Underlying Human Mood

NCT05871372

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

High Selective Subiculum SEEG Guided RF-TC for mTLE-HS

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Intracranial Investigation of Neural Circuity Underlying Human Mood

AI-Based Mobile Intervention on Medication Non-Adherence and Transition

Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment

MEHMO Natural History and Biomarkers