Clinical trial NCT06558864: High Selective Subiculum SEEG Guided RF-TC for mTLE-HS
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mesial Temporal Lobe Epilepsy With Hippocampal Sclerosis
Epilepsy
Keywords: Radio-frequency thermocoagulation
Stereoelectroencephalography
Subiculum
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 20
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: 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 criteria: 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;
* 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 subculum-SEEG Guided RF-TC
Secondary outcomes:
measure: Seizure Responder Rate
timeFrame: Up to 1 year after subculum-SEEG Guided RF-TC
measure: Life quality evaluation
timeFrame: Up to 1 year after subculum-SEEG Guided RF-TC
measure: Cognitive function evaluation (MMSE)
timeFrame: Up to 1 year after subculum-SEEG Guided RF-TC
measure: Cognitive function evaluation (MoCA)
timeFrame: Up to 1 year after subculum-SEEG Guided RF-TC
measure: Adverse Events
timeFrame: Up to 1 year after subculum-SEEG Guided RF-TC
measure: Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)
timeFrame: Up to 1 year after subculum-SEEG Guided RF-TC
Other outcomes:
Locations:
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Liankun Ren, MD
role: PRINCIPAL_INVESTIGATOR
References: