High Selective Subiculum SEEG Guided RF-TC for mTLE-HS (NCT06558864) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
High Selective Subiculum SEEG Guided RF-TC for mTLE-HS
20 participantsStarted 2024-08-09
Plain-language 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).
Who can participate
Age range14 Years – 65 Years
SexALL
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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…
What they're measuring
1
Seizure frequency (SF28)
Timeframe: Up to 1 year after subculum-SEEG Guided RF-TC