Status:
NOT_YET_RECRUITING
High Selective Subiculum SEEG Guided RF-TC for mTLE-HS
Lead Sponsor:
Xuanwu Hospital, Beijing
Conditions:
Mesial Temporal Lobe Epilepsy With Hippocampal Sclerosis
Epilepsy
Eligibility:
All Genders
14-65 years
Phase:
NA
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 t...
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 partici...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 20 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06558864
Start Date
August 9 2024
End Date
August 20 2027
Last Update
August 19 2024
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