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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Процедура Subiculum RF-TC
  SEEG implantation after evaluation, record the interictal and ictal EEG, and perform Subiculum RF-TC.

Первичные конечные точки

• Seizure frequency (SF28) [Срок оценки: Up to 1 year after subculum-SEEG Guided RF-TC]

Вторичные конечные точки (6)

• Seizure Responder Rate [Срок оценки: Up to 1 year after subculum-SEEG Guided RF-TC]
• Life quality evaluation [Срок оценки: Up to 1 year after subculum-SEEG Guided RF-TC]
• Cognitive function evaluation (MMSE) [Срок оценки: Up to 1 year after subculum-SEEG Guided RF-TC]
• Cognitive function evaluation (MoCA) [Срок оценки: Up to 1 year after subculum-SEEG Guided RF-TC]
• Adverse Events [Срок оценки: Up to 1 year after subculum-SEEG Guided RF-TC]
• Incidence of Sudden Unexpected Death in Epilepsy (SUDEP) [Срок оценки: Up to 1 year after subculum-SEEG Guided RF-TC]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06558864 · 2024-174-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗