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临床试验/NCT07110688
NCT07110688招募中不适用

Novel Multimodal Neural, Physiological, and Behavioral Sensing and Machine Learning for Mental States

University of Southern California2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
2
主要终点
Positive and Negative Affect Schedule (PANAS)

研究概览

简要总结

In this program, the investigators will develop novel multimodal neural-behavioral-physiological monitoring tools (software and hardware), and machine learning models for mental states within social processes and beyond. The tools consist of a multimodal skin-like wearable sensor for physiological and biochemical sensing; a conversational virtual human platform to evoke naturalistic social processes; audiovisual affect recognition software; synchronization tools; and machine learning methods to model the multimodal data. The investigators will demonstrate the tools in healthy subjects without neural recordings and in patients with drug-resistant epilepsy who already have intracranial EEG (iEEG) electrodes implanted based on clinical criteria for standard monitoring to localize seizures, which is unrelated to our study.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients who suffer from drug-resistant epilepsy and already have intracranial EEG (iEEG) electrodes implanted based on clinical criteria for their standard seizure localization (unrelated to our study) will be eligible. Most patients are healthy adults outside of their epilepsy.
  • •Subjects >= 18 are only included in this study.
  • •All patients with the above conditions and with already-implanted electrodes who are willing to participate and able to cooperate and follow research instructions will be recruited.

排除标准

  • 未提供

研究组 & 干预措施

Behavioral tasks to assess mental states

Experimental

干预措施: Virtual human social interaction (Behavioral)

Behavioral tasks to assess mental states

Experimental

干预措施: Cold pressor test (Behavioral)

结局指标

主要结局

Positive and Negative Affect Schedule (PANAS)

时间窗: 7-10 days

Momentary self-reports of the Positive and Negative Affect Schedule (PANAS) will be administered in a tablet-based application, which measures momentary positive and negative affect. These self-reports return scores indicative of momentary mental state. Self-reports are obtained intermittently from the participants.

Visual Analog Scale (VAS)

时间窗: 7-10 days

Momentary self-reports of the Visual Analog Scale (VAS) of depression, anxiety, and energy will be administered in a tablet-based application. These are fast self-reports to indicate the affect level along a line from none to prominent. These self-reports return scores indicative of momentary mental state. Self-reports are obtained intermittently from the participants.

Hamilton Depression Rating Scales (HAMD-6)

时间窗: 7-10 days

Momentary self-reports of Hamilton Depression Rating Scales (HAMD-6) will be administered in a tablet-based application, which is widely used to measure the severity of the depressive state. These self-reports return scores indicative of momentary mental state. Self-reports are obtained intermittently from the participants.

Hamilton Anxiety Rating Scales (HAM-A)

时间窗: 7-10 days

Momentary self-reports of Hamilton Anxiety Rating scales (HAM-A) will be administered in a tablet-based application, which is widely used to measure the severity of the anxiety state. These self-reports return scores indicative of momentary mental state. Self-reports are obtained intermittently from the participants.

Immediate Mood Scalar (IMS)

时间窗: 7-10 days

Momentary self-reports of the Immediate Mood Scalar (IMS) will be administered in a tablet-based application, which measures depression and anxiety severity. These self-reports return scores indicative of momentary mental state. Self-reports are obtained intermittently from the participants.

Fear of Negative Evaluation Brief

时间窗: 7-10 days

Momentary self-reports of Fear of Negative Evaluation Brief will be administered in a tablet-based application. These self-reports return scores indicative of momentary mental state. Self-reports are obtained intermittently from the participants.

次要结局

  • Physiological measurements - heart rate variability (HRV)(7-10 days)
  • Physiological measurements - skin conductance (SC)(7-10 days)
  • Physiological measurements - cortisol level(7-10 days)
  • Neural measurements(7-10 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maryam Shanechi

Professor

University of Southern California

研究点 (2)

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