Mapping Low-Intensity Focused Ultrasound (LIFU)-Evoked Brain Network Responses Using Intracranial Electrophysiological Recordings
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Local spectral responses and temporally linked network activity, as measured by intracranial EEG
研究概览
简要总结
The current study presents a unique opportunity to measure the immediate neural responses to brief, non-therapeutic transcranial low-intensity focused ultrasound (LIFU) pulses using intracranial electrodes. By recording time-locked signals in local and distant brain regions we can characterize circuit connectivity in real-time. We will use adult patients undergoing intracranial electrophysiological monitoring in an inpatient setting as our targeted population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who received (or are scheduled to receive) intracranial electrode implantation surgery as part of standard clinical care or as participation in an ongoing research study for the treatment of epilepsy and/or neuropsychiatric conditions at Pennsylvania Hospital (PAH) or Hospital of the University of Pennsylvania (HUP).
- •Adult patients, 21 to 75 years of age
- •Patients considered to be in a stable medical condition, in the opinion of the PI
- •Patients who are able to demonstrate comprehension of instructions in the English language, in the opinion of the PI
- •Patients who are able to provide informed consent and fully comply with all study requirements, in the opinion of the PI
排除标准
- •Patients with chronic alcohol abuse history
- •Patients with additional implanted devices, such as an aneurysm clip, large cranial plates or mesh that may intersect with ultrasonic beam path
- •Open scalp wounds, infection or dermatologic condition that preclude safe placement of ultrasound transducer
- •Intracranial mass lesion with significant mass effect near intended beam path
- •Patients who are pregnant at the time of screening or patients who get pregnant during the course of the study
- •Patients with any past or present medical condition, disease, disorder, or injury that, in the opinion of the PI, may reduce or hinder the participant's ability to fully comply with all study requirements or may impact, compromise, or affect the integrity of the data or the results of the study
研究组 & 干预措施
LIFU Experiment
干预措施: Low Intensity Focused Ultrasound (Device)
结局指标
主要结局
Local spectral responses and temporally linked network activity, as measured by intracranial EEG
时间窗: From enrollment to end of study is two weeks
Safety, as defined by the number and type of adverse events (AE) and change in clinical VAS scales
时间窗: From enrollment to end of study is 2 weeks
次要结局
未报告次要终点
研究者
Katherine Scangos
Associate Professor of Psychiatry
University of Pennsylvania