跳至主要内容
临床试验/NCT05152992
NCT05152992
Enrolling By Invitation
不适用

Spatiotemporal Dynamics of the Human Emotion Network

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 100 人2015年4月20日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Epilepsy
发起方
University of California, San Francisco
入组人数
100
试验地点
1
主要终点
Mean Change from Baseline in Respiratory Rate
状态
Enrolling By Invitation
最后更新
11个月前

概览

简要总结

The overall goal of this study is to elucidate how emotion network dynamics relate to the behavioral, autonomic, and experiential changes that accompany emotions and to investigate how emotion network dysfunction relates to affective symptoms. Affective symptoms are a common feature of neuropsychiatric disorders that reflect dysfunction in a distributed brain network that supports emotion. How aberrant functioning in a single emotion network underlies a wide range of affective symptoms, such as depression and anxiety, is not well understood. Anchored by the anterior cingulate cortex and ventral anterior insula, the emotion network responds to numerous affective stimuli. The recording of neural activity directly from the cortical surface from individuals is a promising approach since intracranial electroencephalography (iEEG) can provide direct estimates of neuronal populations to map the spatiotemporal dynamics of the emotion network at a millisecond level resolution. This study will exam how activity within emotion network hubs changes during emotions and how emotion network properties make some individuals more vulnerable to affective symptoms than others. A multidisciplinary approach is critical for understanding the dynamic brain network to advance neuroanatomical models of emotions and for guiding the development of novel treatments for affective symptoms.

详细描述

Intracranial EEG (iEEG) recordings make it possible to obtain direct measures of emotion network dynamics not possible with other methods. This study proposes to conduct a multimodal assessment of emotions in patients with epilepsy who are undergoing surgery for seizure localization. Electrodes will be placed in sites based on the clinical needs of each patient and will include sites within and outside of the emotion network. The research study team will examine measures of behavior, autonomic nervous system (ANS) activity, and subjective experience to continuous iEEG recordings to determine how emotion network dynamics relate to emotions and affective symptoms. Affective symptoms are common in epilepsy, with nearly one third of patients meeting diagnostic criteria for a severe anxiety or depressive disorder during their lifetimes. This clinical population offers a unique opportunity to obtain direct recordings of emotion network activity with concurrent measures of emotion physiology and behavior. The aims of this study seeks to determine how emotion network activity relates to naturalistic affective behaviors (Aim 1), whether we can uncover the unique neural signatures of discrete emotions and examine their relation to task-based measures of emotional reactivity (Aim 2), and whether electrical stimulation of emotion network changes network activity and alters emotions, mood, and anxiety (Aim 3). Together, these aims will help to uncover the neural mechanisms that produce, sense, and regulate emotions. These results should heavily impact the current understanding of the neurobiological systems that underlie affective symptoms and, therefore, will have significant implications for identifying biomarkers of system dysfunction to guide development of new treatments.

注册库
clinicaltrials.gov
开始日期
2015年4月20日
结束日期
2026年6月30日
最后更新
11个月前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

入排标准

入选标准

  • Participants with epilepsy at UCSF undergoing surgical electrode implantation for seizure localization and
  • Participants with electrodes implanted in at least two regions of interest who are willing and able to cooperate with study tasks.

排除标准

  • Participants who lack capacity or decline to provide informed consent,
  • Participants who have significant cerebral lesions or
  • Participants with cognitive deficits that preclude reliable completion of study tasks.

结局指标

主要结局

Mean Change from Baseline in Respiratory Rate

时间窗: During inpatient hospitalization, approximately 4-14 days

The mean change from baseline in respiratory rate is calculated as the average change in respiratory rate across trials of each emotion video type and stimulated network hub (units: breaths/minute). The change from baseline in respiratory rate on each trial is calculated as: change = (mean respiratory rate during a trial) - (mean respiratory rate prior to the trial). Note: this is one of three components of the autonomic nervous system activity outcome measure.

Mean Facial Expression Activity

时间窗: During inpatient hospitalization, approximately 4-14 days

Mean facial expression activity (units: activation intensity) is quantified for each video emotion type and stimulated network hub. This is measured using the validated Emotional Facial Action Coding System (FACS) to provide a continuous rating of activity in 28 facial muscles using an intensity scale from 1 (trace) to 5 (maximum). The activity scores of all muscles and across the duration of a trial will be summed to quantify the total facial expression activity of that trial. Trials will be averaged for each video emotion type and stimulated network hub to obtain mean facial expression activity.

Mean Change from Baseline in Neural Activity within the Emotion Network

时间窗: During inpatient hospitalization, approximately 4-14 days

The mean change from baseline in neural activity is calculated as the average change in neural activity across trials of each emotion video type and stimulated network hub (units: z-scored neural activity relative to the pretrial baseline). The change from baseline in neural activity on each trial is calculated as: change = (z-scored mean neural activity across the network during a trial) - (z-scored mean neural activity across the network prior to the trial).

Mean change from Baseline in Electrodermal Activity

时间窗: During inpatient hospitalization, approximately 4-14 days

The mean change from baseline in Electrodermal Activity (EDA) is calculated as the average change in EDA across trials of each emotion video type and stimulated network hub (units: microsiemens).The change from baseline in electrodermal activity on each trial is calculated as: change = (mean electrodermal activity during a trial) - (mean electrodermal activity prior to the trial). Note: this is one of three components of the autonomic nervous system activity outcome measure.

Mean Change from Baseline in Heart Rate

时间窗: During inpatient hospitalization, approximately 4-14 days

The mean change from baseline in heart rate is calculated as the average change in heart rate across trials of each emotion video type and stimulated network hub (units: beats/minute). The change from baseline in heart rate on each trial is calculated as: change = (mean heart rate during a trial) - (mean heart rate prior to the trial). Note: this is one of three components of the autonomic nervous system activity outcome measure.

次要结局

  • Mean Subjective Experience(During inpatient hospitalization, approximately 4-14 days)

研究点 (1)

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