Novel Cross-Species Neurophysiological Assays of Reward and Cognitive Domains

NCT ID: NCT02855229

Last Updated: 2024-10-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 222 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-15
• Study Completion Date: 2021-08-31

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.

Conditions

Translational Electrophysiology

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Phase 1 Participants [No Study Drug]

Phase 1 participants are not being assigned to any study drug.

No interventions assigned to this group

Phase 2 Participants [Placebo]

Phase 2 participants that are randomly assigned to the placebo.

No interventions assigned to this group

Phase 2 Participants [Methylphenidate]

Phase 2 participants that are randomly assigned to take methylphenidate.

Methylphenidate

Intervention Type: DRUG

cross-over, single-dose intervention

Phase 2 Participants [Modafinil]

Phase 2 participants that are randomly assigned to take modafinil.

No interventions assigned to this group

Interventions

Methylphenidate

cross-over, single-dose intervention

Intervention Type: DRUG

Other Intervention Names

Modafinil

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mclean Hospital

OTHER

Sponsor Role: lead

Responsible Party

Diego Pizzagalli

Director, Center for Stress, Depression and Anxiety Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diego A Pizzagalli, PhD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

McLean Hospital

Belmont, Massachusetts, United States

Countries

United States

Other Identifiers

2015P001757/MGH

Identifier Type: -

Identifier Source: org_study_id