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Emotion Study -- A Neurofeedback Approach

2020年1月21日 更新者:University of Florida

Emotion Study -- Improving Neural Dysregulation in Advanced Age: A Neurofeedback Approach

This study will determine whether brain activity can be modified and improves performance on a task by showing participants live 'video feed' of their brains on advanced imaging technology. The study is particularly interested in brain regions that have been shown to be relevant for emotions, specifically the anterior insula and the medial prefrontal cortex. Advanced technology will map the brain using magnetic pulses with a real-time functional Magnetic Resonance Imaging (rt-fMRI) machine.

研究概览

详细说明

Overview: All participants of both age groups will be randomly divided (like tossing a coin) into two groups:

  • One group will have training sessions using a special feedback technique to learn to actively increase blood flow in the front of the brain, while thinking of and viewing emotional faces, scenes, and text
  • The other group will have training sessions using a special feedback technique to learn to actively increase blood flow in the back of the brain while thinking of and viewing emotional faces, scenes, and text

Further, each of these two groups will be divided into two sub-groups that are different with respect to the training procedure that is used:

* Use of a 3.0 Tesla, 32-channel Seimens whole-body human MR scanner (fMRI) during training, that has not been associated with any known side effects or safety risks

Number of Study Visits:

This study has the following parts: A pre-training visit, six training visits, and a post-training visit.

With a few exceptions as explained below, the procedures during pre-training, training, and post-training visits are identical.

  • At the beginning of the first visit, the investigator will tell the participant about the study and what is involved and will ask them to sign a consent form. The participant may ask as many questions as they would like before deciding about study participation.
  • For each of the visits, the investigator will review questions with the participant about their health to ensure their eligibility to undergo fMRI on the day of testing.
  • Also for each visit, the investigator will ask the participant to respond to a short questionnaire related to their current mood.
  • In the pre-training and the post-training visits only, the investigator will ask the participant to answer questions about their feelings, emotions, and thoughts.
  • For each of the participant's visits, they will spend 50-60 minutes either in the MRI scanner, while viewing pictures and text on a screen. During this time, pictures of the participant's brain at work and at rest will be acquired. In the training visits only, the participant will learn to increase blood flow in certain brain regions with the help of information presented to them on the screen.
  • For each of the participant's visits, they will be asked to respond to a short questionnaire related to their current mood.
  • In the pre-training/post-training visits only, the investigator will ask the participant to answer questions about their feelings, emotions, and thoughts as well as their personality. The participant will also perform brief tests related to the thinking process.
  • At the end of each visit, the participant will complete a questionnaire about how they approached the study tasks and whether they experienced any discomfort in the MRI scanner or while wearing the fNIRS system.
  • Upon study completion, the investigator will tell the participant about the general goals of the study and answer any questions that they may have.

The procedure can be stopped at any time.

The study will conclude with debriefing and reimbursement.

研究类型

介入性

注册 (实际的)

19

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Florida
      • Gainesville、Florida、美国、32611-2250
        • University of Florida

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 90年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Between the ages of 18-30 years or 63-90 years
  • Right-handed
  • Native English speaker

Exclusion Criteria:

  • Pregnant or possibly pregnant
  • Claustrophobia
  • Large pieces of metal in the body, particularly in the face and neck.
  • Piercings or metal implants that cannot be removed from the body
  • Surgery on the brain or any prior serious brain damage or disease
  • Dementia or severe cognitive disorders

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Anterior insula cortex activation
Participants will receive training sessions using a special feedback technique to learn to actively increase blood flow in the front of the brain, while thinking of and viewing emotional faces, scenes, and text.
training sessions using a special feedback technique to learn to actively increase blood flow in the front of the brain
有源比较器:Primary auditory cortex activation
Participants will have training sessions using a special feedback technique to learn to actively increase blood flow in the back of the brain while thinking of and viewing emotional faces, scenes, and text.
training sessions using a special feedback technique to learn to actively increase blood flow in the back of the brain

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Increased activation of anterior insula from pre-training to post-training
大体时间:Pre-training session (baseline visit); post-training session (approximately one week later)
Both young and older participants can be trained in up-regulation of anterior insula activity, by means of contingent neurofeedback (rt-fMRI), reflecting continued plasticity of brain regions associated with affective processing.
Pre-training session (baseline visit); post-training session (approximately one week later)

次要结果测量

结果测量
措施说明
大体时间
Gained volitional control over activity in anterior insula improves emotion perception from pre-training to post-training
大体时间:Pre-training (baseline visit); post-training visit (approximately one week later)
Participants in the experimental group compared to the control group will benefit more from neurofeedback, in that they will show relatively greater improvement in emotion perception after the rt-fMRI training, reflecting a potential for improvement of neural dysregulation related to affective processing.
Pre-training (baseline visit); post-training visit (approximately one week later)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Natalie Ebner, PhD、University of Florida, Department of Psychology

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年10月1日

初级完成 (实际的)

2020年1月8日

研究完成 (实际的)

2020年1月8日

研究注册日期

首次提交

2014年7月10日

首先提交符合 QC 标准的

2014年7月17日

首次发布 (估计)

2014年7月18日

研究记录更新

最后更新发布 (实际的)

2020年1月22日

上次提交的符合 QC 标准的更新

2020年1月21日

最后验证

2020年1月1日

更多信息

与本研究相关的术语

其他研究编号

  • IRB201300814 closed

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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