Piriform Cortex Electrical Stimulation for Temporal Lobe Epilepsy With Biliteral Hippocampus Sclerosis

Обзор

The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of Piriform cortex as adjunctive therapy for reducing the frequency of seizures in drug-resistant temporal lobe epilepsy with bilateral hippocampal sclerosis

Подробное описание

This project aims to include 5 participants, and evaluate the effectiveness and safety of piriform cortex stimulation in patients with temporal lobe epilepsy and bilateral hippocampal sclerosis through A prospective, interventional, unblinded, single-arm clinical trial. It is expected to provide new therapeutic options for patients with temporal lobe epilepsy and bilateral hippocampal sclerosis with alternative treatment options.

Вмешательства

• Устройство piriform cortex-DBS
  The surgical intervention named deep brain stimulation is a well-established neurosurgical treatment for drug-resistant epilepsy.The targets used in this study are biliteral piriform cortex.The devices used for intervention have been approved by Chinese National Medical Products Administration (CFDA). The postoperative drug dosage adjustment depends on the efficacy of DBS and the judgment of the epilepsy specialist.

Первичные конечные точки

• Seizure frequency (SF28) [Срок оценки: Up to 1 year after piriform cortex-DBS]

Вторичные конечные точки (6)

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

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 3 times per 3 months or greater, and once or more in recent 1 month.
• After comprehensive preoperative evaluation, patients who are considered unsuitable for or refuse resection surgery, or those for whom the effects of epileptic focus resection and thermocoagulation surgery are not satisfactory.
• Participants must have had a non-invasive video-EEG monitoring revealing seizure semiology and ictal EEG consistent with bilateral Temporal Lobe Epilepsy
• Biliteral hippocampal atrophy on MRI T1 imaging with increased ipsilateral mesial signal on T2 imaging
• Informed consent signed.

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: NCT07128563 · 2025-212-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗