Mapping Transcrnial Magnetic Stimulation (TMS) Responses Within the Brain Using Intracranial Electrophysiological Monitoring Recordings
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Primary Endpoint #2: Safety Feasibility
研究概览
简要总结
The current study presents a unique opportunity to measure the direct effects of transcranial magnetic stimulation (TMS) by using intracranial electrodes to record neural activity in deep brain regions when TMS single pulses are delivered. If TMS can evoke downstream responses in neural networks of the human brain, it can be a feasible way to study circuit engagement and connectivity.
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 neurological and/or psychiatric conditions at Pennsylvania Hospital
- •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 who are unable to have an MRI scan
- •Patients who are unable to tolerate TMS
- •Patients with additional implanted devices, such as an aneurysm clip or a cardiac pacemaker, that would increase the TMS risk profile
- •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
TMS
The study visit consists of a TMS single-pulse session when intracranial electrodes are implanted to record neural activity during the TMS session.
干预措施: Single Pulse TMS (Device)
结局指标
主要结局
Primary Endpoint #2: Safety Feasibility
时间窗: From enrollment to end of study participation at 5 weeks.
Safety, as defined by the number of adverse events (AE)
Primary Endpoint #1 Brain Activity and Connectivity
时间窗: From enrollment to the end of study participation at 5 weeks
Observation of effects in brain activity and connectivity within and across regions of interest before and after TMS, as measured by intracranial EEG. The evoked response magnitude from the EEG at all features of the time-frequency analysis are used.
次要结局
未报告次要终点
研究者
Katherine Scangos
Associate Professor of Psychiatry
University of Pennsylvania