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临床试验/NCT06159595
NCT06159595已完成不适用

Behavioral and Neuronal Correlates of Human Mood States

Stanford University1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2023年12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
已完成
入组人数
11
试验地点
1
主要终点
Quantitative Audio-Facial Change

研究概览

简要总结

Optimizing treatments in mental health requires an easy to obtain, continuous, and objective measure of internal mood. Unfortunately, current standard-of-care clinical scales are sparsely sampled, subject to recency bias, underutilized, and are not validated for acute mood monitoring. The recent shift to remote care also requires novel methods to measure internal mood. Recent advances in computer vision have allowed the accurate quantification of observable speech patterns and facial representations. The continuous and objective nature of these audio-facial behavioral outputs also enable the study of their neural correlates. Here, the investigators hypothesize that video-derived audio-facial behaviors have discrete neural representations in the limbic network and can provide a critical set of reliable longitudinal estimates of mood at low cost across home and clinic settings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age range between 18 and 65
  • Major depressive disorder (MDD) in a current major depressive episode diagnosed with the Mini-International Neuropsychiatric Interview (MINI)
  • No medical or surgical contraindication to electrode implantation
  • Patient capable of understanding the scope of our project or signing informed consent independently.

排除标准

  • Diffuse epilepsy involving several lobes of the brain

研究组 & 干预措施

Active Direct electrical stimulation (DES)

Active Comparator

Intracranial electrodes will be used for the delivery of invasive brain stimulation.

干预措施: Intracranial electrodes (Device)

Sham Direct electrical stimulation (DES)

Sham Comparator

Intracranial electrodes will be used for the delivery of invasive brain stimulation.

干预措施: Intracranial electrodes (Device)

结局指标

主要结局

Quantitative Audio-Facial Change

时间窗: 5 minutes

Quantitative percent change in each audio-facial feature before and after direct electrical stimulation at each site.

Quantitative Mood Change

时间窗: 5 minutes

Quantitative percent change in Immediate Mood Scaler (IMS) after direct electrical stimulation at each site compared to a baseline period before sham. The minimum score on the IMS is 7 and the maximum is 154, with lower scores reflecting more negative mood states.

次要结局

  • Correlation between Audio-Facial and Mood Change(5 minutes)
  • Qualitative Mood Change(5 minutes)

研究者

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

Corey Keller

Principal Investigator, Associate Professor

Stanford University

研究点 (1)

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