Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Neurophysiological activity
研究概览
简要总结
Anxiety disorders such as post-traumatic stress disorder (PTSD) and generalized anxiety disorder (GAD) affect a large number of individuals with a significant portion of patients failing to improve with current treatments.
The purpose of this study is to understand the brain mechanisms that produce fear and anxiety in humans. To accomplish this goal, we will measure the brain activity along with the heart rate and skin perspiration of patients while they are completing tasks on a computer. Some of the tasks will also use a virtual reality headset and transport the patient in a video game-like environment. These tasks will expose the participants to various levels of fear-provoking images. Participants with responsive neurostimulation (RNS) implants will be enrolled under Pro00117931 at Duke, but their results for fear and anxiety tasks will be reported under NCT05120635.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Has undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement
- •Willing to provide informed consent and participate in the study
- •Ability to read and write English fluently
排除标准
- •Unwilling to provide informed consent
- •Has not undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement
- •Pregnant women
- •Participants with active psychosis
- •Participants with suicidal ideation
- •Participants with substance abuse issues
研究组 & 干预措施
EMU Participants
Subjects participating in the study at the Epilepsy Monitoring Unity (EMU).
干预措施: Deep Brain Stimulation (Device)
EMU Participants
Subjects participating in the study at the Epilepsy Monitoring Unity (EMU).
干预措施: Virtual and augmented reality tasks (Behavioral)
RNS Participants
Subjects with RNS implants.
干预措施: Deep Brain Stimulation (Device)
RNS Participants
Subjects with RNS implants.
干预措施: Virtual and augmented reality tasks (Behavioral)
结局指标
主要结局
Neurophysiological activity
时间窗: during the intervention/behavioral tasks with and without stimulation
Neurophysiological activity will be measured in Hz
Physiological change - heart rate variability
时间窗: during the intervention/behavioral tasks with and without stimulation
heart rate variability will be measured in milliseconds.
Physiological change - skin conductance
时间窗: during the intervention/behavioral tasks with and without stimulation
Skin conductance will be measured in microSiemens.
Physiological change - eye-blinks
时间窗: during the intervention/behavioral tasks with and without stimulation
Eye blinks will be measured using an eye tracking device and will be measure in blinks per second.
次要结局
未报告次要终点