Translational ElectrophysiologyNCT02855229
Novel Cross-Species Neurophysiological Assays of Reward and Cognitive Domains
An observational study of Translational Electrophysiology, run by Mclean Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Translational Electrophysiology
- What is being tested?
- Methylphenidate
- How many people
- 222 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2020to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adults
Who may be able to join
- Healthy adults
- Right-handed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
- advanced neurophysiological and computational modeling techniques to record and analyze EEG activity within and across species; and
- 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.
Read the 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
- Being tested
- Methylphenidate
- Keywords
- Translational, Electrophysiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Also called Modafinil
cross-over, single-dose intervention
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Participants [No Study Drug] | Phase 1 participants are not being assigned to any study drug. | |
| Phase 2 Participants [Placebo] | Phase 2 participants that are randomly assigned to the placebo. | |
| Phase 2 Participants [Methylphenidate] | Phase 2 participants that are randomly assigned to take methylphenidate. Receives: Drug: Methylphenidate | |
| Phase 2 Participants [Modafinil] | Phase 2 participants that are randomly assigned to take modafinil. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feedback-related positivity (FRP) amplitudes over frontocentral scalp regions in response to rewarded trials versus no-reward trials.
Relative FRP response is the primary outcome measure for the probabilistic reward task (PRT) used in Phase 1.
Measured: 1 Day
Event-related negativity (ERN) amplitudes over frontocentral scalp regions in response to correct trials versus incorrect trials.
Relative ERN response is the primary outcome measure for the flanker task.
Measured: 1 Day
Feedback-related negativity (FRN) amplitudes over frontocentral scalp regions in response to negative feedback versus positive feedback.
Relative FRN response is the primary outcome measure for the reversal learning task.
Measured: 1 Day
Behavioral Performance on the Flanker Task
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.
Measured: 1 Day
Behavioral Performance on the Reversal Learning Task
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.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study start15 Aug 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Translational ElectrophysiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Pizzagalli, Mclean Hospital
- Investigators
- Diego A Pizzagalli, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855229
- Sponsor's protocol ID
- 2015P001757/MGH
- Status last verified
- Jan 2023
- First submitted
- 11 Jul 2016
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- Yes: All collected IPD will be shared via NIMH Data Archive (as part of data submission agreement)
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Cross-Species Neurophysiological Assays of Reward and Cognitive Domains
- ClinicalTrials.gov ID
- NCT02855229
- Acronym / sponsor ID
- 2015P001757/MGH
- Conditions
- Translational Electrophysiology
- Keywords
- Translational, Electrophysiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- advanced neurophysiological and computational modeling techniques to record and analyze EEG activity within and across species; and
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Participants [No Study Drug] | – | –Phase 1 participants are not being assigned to any study drug. |
| Phase 2 Participants [Placebo] | – | –Phase 2 participants that are randomly assigned to the placebo. |
| Phase 2 Participants [Methylphenidate] | – | Drug: MethylphenidatePhase 2 participants that are randomly assigned to take methylphenidate. |
| Phase 2 Participants [Modafinil] | – | –Phase 2 participants that are randomly assigned to take modafinil. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults
Key inclusion criteria (2 listed)
- Healthy adults
- Right-handed
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylphenidateAlso: Modafinilcross-over, single-dose intervention | Drug | Phase 2 Participants [Methylphenidate] |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: Yes. All collected IPD will be shared via NIMH Data Archive (as part of data submission agreement)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego A Pizzagalli, PhD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Translational Electrophysiology, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feedback-related positivity (FRP) amplitudes over frontocentral scalp regions in response to rewarded trials versus no-reward trials. (time frame: 1 Day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.