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OpenTrials
Completed

NCT Number: NCT02855229

Novel Cross-Species Neurophysiological Assays of Reward and Cognitive Domains

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.

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Key information

Conditions

Translational Electrophysiology

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adults
  • Right-handed

Exclusion criteria

  • 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

Treatment and study plan

Methylphenidate

Drug

cross-over, single-dose intervention

Other names: Modafinil

Primary outcomes

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

    Time frame: 1 Day

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

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

    Time frame: 1 Day

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

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

    Time frame: 1 Day

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

  4. Behavioral Performance on the Flanker Task

    Time frame: 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.

  5. Behavioral Performance on the Reversal Learning Task

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 4, 2016
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.