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临床试验/NCT05929898
NCT05929898招募中不适用

Bridging Scales to Understand Endogenous Neuromodulation and Its Regulation

Duke University2 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2023年7月30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
190
试验地点
2
主要终点
Percent signal change in VTA BOLD activation

研究概览

简要总结

The purpose of this research study is to understand how healthy individuals self-regulate motivation by observing brain activity using magnetic resonance imaging (MRI).

详细描述

Neuromodulatory nuclei detect and transform brain network activity into simpler signals, then send neurotransmitters back out to large-scale brain networks to change their function. Such nuclei are centrally implicated in mental disorders and adaptive resilience, and their regulation remains an untapped resource for interventions. The purpose of this study is to understand how neuromodulatory nuclei detect and in turn influence distributed patterns of brain activity to impact behavior. In order to understand their regulation and effects on brain function, the investigative team has developed novel neuroimaging, behavioral, and analytic methods. These methods include: training participants to endogenously self-regulate dopaminergic midbrain and then relating midbrain activation to memory-conducive states, effort exertion, and decision making.

If the aims of this project are achieved, the investigators will have methods for regulating midbrain noninvasively, an improved understanding of its impact on learning and motivated behavior, and reliable cognitive strategies for a wide array of interventions across educational and clinical applications.

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 45 years
  • Right-handed
  • In good general health

排除标准

  • Current or diagnosis within past six months of an DSM-V Axis I or Axis II disorder (self-reported)
  • CES-D score of 20 or higher (indicating significant current depression symptoms)
  • Current or past six month use of prescription medications indicated for psychiatric conditions (e.g.,depression, anxiety)
  • Current serious medical illness (self-reported)
  • Head injury resulting in loss of consciousness
  • For participants age > 59 years, a total scaled score < 8 on the Dementia Rating Scale-
  • A clinically-defined neurological disorder including, but not limited to:
  • Any condition likely to be associated with increased intracranial pressure
  • Space occupying brain lesion
  • History of stroke
  • Transient ischemic attack within two years
  • Cerebral aneurysm
  • Mini Mental Status Exam (MMSE) score of <24
  • Parkinson's disease
  • Huntington's disease
  • Multiple sclerosis
  • Presence of cochlear implants or other implanted electronic devices or non-removable metal (e.g., non-removable piercing, IUD)
  • History of an eye injury involving metal. Participants who worked with metal may be allowed to participate on a case-by-case basis with prior written approval from BIAC.
  • Claustrophobia or unwillingness to tolerate the confinement associated with being in the MRI scanner.
  • Weight of more than 250 pounds

研究组 & 干预措施

Intentional Versus Cue-Evoked Midbrain Activation

Experimental

Participants meeting study inclusion will be scheduled for two sessions: one baseline behavioral visit and an fMRI session to assess the ability to self-stimulate VTA activation. Session one will include a battery of cognitive assessments and a demonstration of the reward-based learning task in session two. The experimental imaging task session will be done within one week of session one. Participants will been randomly split into two group: group one will complete a reward-based learning task before the VTA activation task and group two will complete reward task after VTA activation. During the VTA activation task, participants will be instructed to achieve a heightened state of motivation using personally relevant thoughts and imagery.

干预措施: Ventral tegmental area of dopaminergic midbrain (VTA) fMRI neurofeedback (Behavioral)

Intentional Midbrain Activation Effects on Effort-Based Decision Making

Experimental

Participants will be randomly assigned to an MRI group or a behavioral control group. All participants will complete an effort-based learning task and a series of questionnaires in session one. Session two may include an MRI based on group assignment. Participants in the MRI group will complete the VTA activation task. Following, they will complete the effort task and questionnaires a second time. The behavioral control group will complete a second session consisting of the effort task and questionnaires.

干预措施: Ventral tegmental area of dopaminergic midbrain (VTA) fMRI neurofeedback (Behavioral)

Intentional Midbrain Activation Effects on Motivated Memory

Experimental

Participants will take part in four sessions: visit 1-baseline + memory encoding, visit 2-memory retrieval, visit 3-memory encoding, visit 4-memory retrieval). Encoding and retrieval of the memoranda will occur 24 hours apart. Study visits will take place no more than 7 days apart. One group of participants will complete all sessions at the Center for Cognitive Neuroscience. The remainder of participants will complete the encoding sessions in the MRI machine, .

干预措施: Ventral tegmental area of dopaminergic midbrain (VTA) fMRI neurofeedback (Behavioral)

结局指标

主要结局

Percent signal change in VTA BOLD activation

时间窗: During the MRI scan, approximately 2 hours

次要结局

  • Change in motivated memory, as measured by the Monetary Incentive Encoding task (MIE)(During the MRI scan, approximately 2 hours)
  • Change in effort-based decision making, as measured by the Effort Expenditure for Reward Task (EEfRT)(During the MRI scan, approximately 2 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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