Clinical trial NCT02855229: Novel Cross-Species Neurophysiological Assays of Reward and Cognitive Domains
Official title: Novel Cross-Species Neurophysiological Assays of Reward and Cognitive Domains
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Translational Electrophysiology
Keywords: Translational
Electrophysiology
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feedback-related positivity (FRP) amplitudes over frontocentral scalp regions in response to rewarded trials versus no-reward trials.
timeFrame: 1 Day
measure: Event-related negativity (ERN) amplitudes over frontocentral scalp regions in response to correct trials versus incorrect trials.
timeFrame: 1 Day
measure: Feedback-related negativity (FRN) amplitudes over frontocentral scalp regions in response to negative feedback versus positive feedback.
timeFrame: 1 Day
measure: Behavioral Performance on the Flanker Task
timeFrame: 1 Day
measure: Behavioral Performance on the Reversal Learning Task
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Diego A Pizzagalli, PhD
role: PRINCIPAL_INVESTIGATOR
References: