NCT05844696尚未招募1 期
Electrical Neuromodulation for Focal Epilepsy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 65
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
The purpose of this research is to use electrical neuromodulation on patients with focal epilepsy. The main objective is to assess safety and observe potential therapeutic effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 years old.
- •Focal epilepsy patients having received EEG and brain imaging studies and on standard medication.
- •Age ≥ 20 years old.
- •Focal epilepsy patients having received EEG and brain imaging studies and on standard medication for at least 1 year.
- •Having received part I intervention.
排除标准
- •Patients with secondary and progressive macrostructural abnormalities in the brain, such as brain tumors or infectious lesions. This does not include abnormalities directly related to epilepsy, such as mesial temporal sclerosis or focal dysplasia.
- •Patients who are unable to undergo brain electrical stimulation, including those with metal in the brain or implanted stimulators/implants.
- •Patients with allergies to the sponge material used for stimulation.
- •Patients with wounds or infections at the site of sponge application.
- •Patients with intellectual disabilities, manic episodes (with a score of greater than 12 on the Young Mania Rating Scale), major physiological illnesses (such as stroke, brain tumors, or heart attacks), or pregnant or breastfeeding women.
- •Patients judged by the physician to be unsuitable for the clinical trial due to unstable vital signs or serious internal or external medical conditions.
- •Patients with secondary and progressive macrostructural abnormalities in the brain, such as brain tumors or infectious lesions. This does not include abnormalities directly related to epilepsy, such as mesial temporal sclerosis or focal dysplasia.
- •Patients who could be considered for single focus resection based on the neurologist/neurosurgeon's judgment. However, patients who clearly refuse resection surgery are not subject to this limitation.
- •Patients who experience serious adverse events (SAEs) during the part 1 trial.
- •Patients who are unable to undergo magnetic resonance imaging (MRI).
- •Patients who are planned to receive hyperthermia therapy or transcranial magnetic stimulation.
- •Patients judged by the physician to be unsuitable for the clinical trial due to unstable vital signs or serious internal or external medical conditions.
结局指标
主要结局
Number of participants with adverse events
时间窗: 3 months
Any noxious, unintended and undesired effect
次要结局
- The seizure frequency per month(3 months)
研究者
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