Lovastatin Modulation of the Inhibition-excitation Balance in Temporal Lobe Onset Drug Resistant Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Neurochemical response changes to GABAergic stimulation
研究概览
简要总结
This study aims to investigate the effect of lovastatin on neurotransmission and neuroinflammation in patients with temporal lobe onset drug resistant epilepsy.
Structure: (1) Visit 1: 3 consecutive days of physiologically probing drug/placebo intake, (2) Visit 2: Outcome measures and additional evaluations in the day after the last drug/placebo intake, (3) Washout period of 4 weeks, (4) 3 consecutive days of drug/placebo intake, (5) Visit 3: Outcome measures and additional evaluations in the day after the last placebo/drug intake.
详细描述
This study investigates the potential therapeutic effects of lovastatin, a drug known for its anti-inflammatory and neuroprotective properties, in patients with temporal lobe drug-resistant epilepsy (DRE). Emerging evidence suggests that inflammation plays a significant role in epileptogenesis, and preclinical models of epilepsy have demonstrated the efficacy of statins in reducing seizure susceptibility.
This pilot, double-blinded, placebo-controlled crossover study included five participants with focal-onset DRE. The primary objectives were to evaluate the impact of lovastatin on cortical inhibition, oxidative stress, and seizure activity. Participants received 60 mg/day of lovastatin or placebo for a specified period, with treatment phases separated by a washout period.
Key assessments included magnetic resonance spectroscopy (MRS) to measure brain metabolites such as GABA, glutamate, and glutathione in the occipital cortex. Event-related potentials (ERP) were recorded during a facial recognition task to examine visual evoked potentials, while resting EEG was used to analyze interictal epileptiform discharges (IEDs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of pharmacoresistant epilepsy as defined by the International League Against Epilepsy,
- •focal temporal lobe onset
- •nonpregnant and nonlactating in women
排除标准
- •history of cardiovascular or cerebrovascular disease,
- •history of dyslipidemia, previous use of statins or a previously documented adverse reaction to statins,
- •having any metal inside the head but outside the mouth,
- •implanted devices such as cardiac pacemakers or cochlear implants,
- •having a vagal nerve stimulation device and the presence of other comorbid neurologic conditions
研究组 & 干预措施
Lovastatin
干预措施: Lovastatin 60 MG (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Neurochemical response changes to GABAergic stimulation
时间窗: First day after placebo and first day after lovastatin intervention.
Comparing changes in brain excitation-inhibition measures (i.e., glutamate and GABA) when the GABAergic system is activated by oral dose of the Lovastatin 60mg during 3 days versus the placebo condition.
Evaluation of neuroinflammation by measuring Glutathione as a marker of oxidative stress
时间窗: First day after placebo and first day after lovastatin intervention.
次要结局
未报告次要终点
研究者
Miguel Castelo-Branco
Prof Dr
University of Coimbra