跳至主要内容
临床试验/NCT02855229
NCT02855229已完成不适用

Novel Cross-Species Neurophysiological Assays of Reward and Cognitive Domains

Mclean Hospital1 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2020年8月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
222
试验地点
1
主要终点
Feedback-related positivity (FRP) amplitudes over frontocentral scalp regions in response to rewarded trials versus no-reward trials.

研究概览

简要总结

The overarching goal of this multi-disciplinary research program is to develop and optimize new cross-species translational assessments of reward and cognition that will not only be assessed in parallel in humans and rats, but also produce neurophysiological and behavioral metrics that can be objectively compared across species. The research will build on prior studies by further developing and optimizing (in Phase 1), then validating via pharmacological challenge (in Phase 2), the following assays in both humans and rats:

  1. advanced neurophysiological and computational modeling techniques to record and analyze EEG activity within and across species; and
  2. behavioral assessments of reward learning, cognitive control, and cognitive flexibility will be analyzed within and across species.

The second phase of the study will test the translational validity of these assays, by assessing the impact of a targeted drug on task performance and EEG activity in both species.

详细描述

The overarching goal of this multi-disciplinary research program is to develop and optimize new translational assessments of reward and cognition that will produce neurophysiological and behavioral metrics that enable objective comparison of drug effects.

Phase 1 (2016-2018) will seek to develop and optimize computer-based tasks to measure of reward learning and cognition, to be administered during an EEG examination. Each participant will be asked to come for a single visit to complete a brief psychological assessment (interview and surveys), then perform two of the computer-based tasks while EEG data are collected. The three tasks are the Flanker Task, the Reversal Learning Task, and the Probabilistic Reward Task (PRT).

In Phase 2 (2018-2021), a new set of participants will be enrolled for four visits. At the first visit they will have a brief psychological assessment (interview and surveys). They will then be assigned to one of the tasks developed during Phase I, and they will also be assigned to one of the study drugs: modafinil (a cognitive enhancer) or methylphenidate (a dopamine enhancer). At the second, third, and fourth visit, the subject will be given their drug in one of the three doses: a low dose, a higher dose, and a placebo. They will then perform the assigned task during an EEG exam.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Healthy adults
  • Right-handed

排除标准

  • acute or chronic medical, neurological, or psychiatric illness
  • any past/current diagnosis of mental health disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), including alcohol or substance abuse;
  • use of any psychotropic medications in the past 6 months
  • Current depressed mood (Beck Depression Inventory (BDI-II) score < 6)
  • Current use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, and other anticoagulants
  • History of cocaine, stimulant, and other dopaminergic drug use (e.g., amphetamine, methylphenidate)
  • Positive toxicology screen at any session

研究组 & 干预措施

Phase 2 Participants [Methylphenidate]

Phase 2 participants that are randomly assigned to take methylphenidate.

干预措施: Methylphenidate (Drug)

结局指标

主要结局

Feedback-related positivity (FRP) amplitudes over frontocentral scalp regions in response to rewarded trials versus no-reward trials.

时间窗: 1 Day

Relative FRP response is the primary outcome measure for the probabilistic reward task (PRT) used in Phase 1.

Event-related negativity (ERN) amplitudes over frontocentral scalp regions in response to correct trials versus incorrect trials.

时间窗: 1 Day

Relative ERN response is the primary outcome measure for the flanker task.

Feedback-related negativity (FRN) amplitudes over frontocentral scalp regions in response to negative feedback versus positive feedback.

时间窗: 1 Day

Relative FRN response is the primary outcome measure for the reversal learning task.

Behavioral Performance on the Flanker Task

时间窗: 1 Day

The Flanker Task is a cognitive task that measures response inhibition to assess the ability to suppress responses that are inappropriate in a particular context.

Behavioral Performance on the Reversal Learning Task

时间窗: 1 Day

The task involves learning 'rule' which determine which of two abstract stimuli are selected. The rule changes in the middle of the block, and the goal is to see how quickly the participant can adapt to the rule change. Feedback is probabilistic.

次要结局

未报告次要终点

研究者

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

Diego Pizzagalli

Director, Center for Stress, Depression and Anxiety Research

Mclean Hospital

研究点 (1)

Loading locations...

相似试验