The Efficacy and Safety of Pallidothalamic Tracts Electrical Stimulation for Lennox-Gastaut Syndrome: A Prospective, Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Liankun_Ren
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Seizure Frequency (SF28)
研究概览
简要总结
The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of pallidothalamic tracts as adjunctive therapy for alleviating symptoms in Lennox-Gastaut Syndrome.
详细描述
This project aims to include 5 participants, and evaluate the effectiveness and safety of pallidothalamic tracts stimulation in patients with Lennox-Gastaut Syndrome through a prospective, interventional, unblinded, single-arm clinical trial. It is expected to provide new therapeutic options for patients with Lennox-Gastaut Syndrome with alternative treatment options.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the diagnostic criteria for Lennox-Gastaut Syndrome (LGS) based on comprehensive assessment of medical history, seizure semiology, and electroencephalographic (EEG) findings during both ictal and interictal periods;
- •Interictal EEG demonstrates generalized paroxysmal fast activity (GPFA) and slow spike-and-wave (SSW) complexes;
- •Generalized tonic-clonic seizures (GTCs) have been captured in prior video-EEG monitoring, or seizure episodes have been clearly described by reliable eyewitnesses;
- •During the screening or baseline period, the following conditions are met:
- •The patient or caregiver is capable of reliably maintaining a seizure diary;
- •The seizure diary indicates an average of at least 5 seizures per month;
- •The patient is on two or more antiepileptic drugs (AEDs), with a stable treatment regimen (no new add-on or withdrawal of AEDs, excluding temporary rescue medications such as benzodiazepines; dose adjustments are allowed);
- •The patient has been evaluated through a comprehensive presurgical epilepsy workup and is considered unsuitable for, or has declined, resective epilepsy surgery, or has had unsatisfactory outcomes from resective or ablative procedures;
- •Providation of written informed consent, demonstrates adequate compliance with the study protocol, and agrees to participate in this clinical study.
排除标准
- •Unable to provide a reliable seizure diary by self or legal guardian;
- •Predominant seizure type is focal impaired awareness seizures;
- •Psychogenic non-epileptic seizures within 12 months;
- •Brain structual abnormalities precluding safe implantation of deep brain stimulator;
- •Conditions associated with increased risk of intraoperative or postoperative bleeding (e.g., coagulopathy), or requirement for long-term oral anticoagulant or antiplatelet therapy;
- •Presence of other severe somatic or internal medical conditions, including significant hepatic or renal dysfunction;
- •Pregnant, or planning to pregnant within 2 years.
研究组 & 干预措施
Pallidothalamic Tracts-DBS group
participants will undergo Pallidothalamic Tracts-DBS ON with the individual stimulation parameters determined in the parameter determination period, then continue to receive stimulation for the remainder of the study.
干预措施: Forel's Field H-DBS ON (Device)
结局指标
主要结局
Seizure Frequency (SF28)
时间窗: Up to 1 year after Forel's Field H-DBS
Seizure frequency (SF28) is defined as seizure count per month (28-day) period. The SF28 is calculated as follows, where D=total number of days for which seizure information is collected for the specific 28-day interval: SF28=(Total number of seizures in D days/D)\*28. In addition, the baseline seizure frequency is defined as mean of 3- month SF28 in the baseline period. The seizure frequency in double-blind phase is defined as SF28 per month during the double-blind period. Percent change in seizure frequency=100\*(double-blind SF28-baseline SF28)/baseline SF28.
次要结局
- Adverse Events(Up to 1 year after Pallidothalamic Tracts-DBS)
- Life quality evaluation(Up to 1 year after Forel's Field H-DBS)
- Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)(Up to 1 year after Forel's Field H-DBS)
- Seizure Responder Rate(Up to 1 year after Forel's Field H-DBS)
- Cognitive function evaluation (MMSE)(Up to 1 year after Forel's Field H-DBS)
- Cognitive function evaluation (MoCA)(Up to 1 year after Forel's Field H-DBS)