NCT07680842招募中不适用
Pilot Study of Non-Invasive Low Intensity Focused Ultrasound as an Adjunctive Treatment for Drug-Resistant Epilepsy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Seizure Frequency
研究概览
简要总结
The goal of this study is to investigate the effects of a non-invasive, low intensity focused ultrasound (LIFU) stimulation on seizure frequency and the epileptogenic network in drug-resistant epilepsy. LIFU uses focused sound waves to modulate deep brain regions and to enable changes in brain network activity. Encephalography (EEG) and behavioral tasks will also be used to study how LIFU affects brain activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between 21 and 65 years of age at screening
- •Clinical diagnosis of drug-resistant epilepsy with on average, 4 or more seizures per month.
- •Able to provide informed consent (or assent when applicable) by the subject or subject's legal representative.
- •Be willing to undergo a brain MRI.
- •Be able and willing to wear a headband during the treatment duration.
- •Be able to complete scheduled visits and daily seizure logs.
排除标准
- •Has a craniotomy or pathologic intracranial lesion (e.g. vascular malformations) in the trajectory of the focused ultrasound beam.
- •Pregnant, breastfeeding, is attempting pregnancy, or unwilling to practice birth control during participation in the study.
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- •Has any unstable medical or psychiatric disease.
- •Any contraindications for completing a brain MRI scan.
- •Has evidence of any other clinically relevant neurological disorder at the time of screening, including Alzheimer's disease, frontotemporal dementia, Huntington's disease, amyotrophic lateral sclerosis, and multiple sclerosis.
结局指标
主要结局
Seizure Frequency
时间窗: Seizure counts will be obtained daily for at least 1 month prior to the first study visit, throughout the study which averages around 4 months, and monitored for up to 2 months after the final visit.
Seizure counts will be obtained from a seizure diary kept by each participant.
次要结局
- LIFU induced network change based on fMRI and/or electrophysiology(Obtained at the baseline visit and the final day of serial stimulation, which averages around 4 months.)
- Cognitive battery(The cognitive battery will be performed at baseline visit, as well as at the beginning and end of routine study visits; the duration averages around a 4 month period.)
研究者
研究点 (1)
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