The Computational and Neural Mechanisms Linking Decision-making and Memory in Humans

December 15, 2025 updated by: Salman Ehtesham Qasim, Ph.D., Rutgers, The State University of New Jersey
Learning to make good decisions in the present, and accurately recalling events and information from the past, are critical aspects of human cognition that are often impaired in many psychiatric disorders. This project aims to identify the how the choices individuals make influence what, and how, people remember by combining disparate techniques in computational modeling and direct brain recordings in human subjects. The researcher developed a dual-task paradigm, probing how decisions in one task affect immediate recognition memory. To examine the neural mechanisms underlying model-free RL's influence on memory, the researcher will record local field potential (LFP) and single neuron activity in various brain regions as epilepsy patients perform the proposed task. The results of this project will identify specific neurocomputational mechanisms unifying decision-making and memory processes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Robert Wood Johnson Medical School
        • Principal Investigator:
          • Salman E Qasim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has seizure activity which is deemed non-responsive to standard pharmacological intervention(s), as determined by treating Neurologist and established clinical practices
  • Has elected to receive clinically indicated intracranial EEG (electrocorticography (ECoG), stereoelectroencephalography (SEEG)) and/or temporal responsive neurostimulation (RNS) for medication-refractory epilepsy outside of this research study, as determined by treating clinician(s) and per current clinical practice
  • Capacity to provide written informed consent
  • Language proficiency in English or Spanish
  • Willing and able to comply with all study-related procedures

Exclusion Criteria:

  • History of psychosis, such as in the context of depressive or manic episode.
  • Active suicidal ideation with intent, suicide attempt within the last six months, or other serious suicide risk
  • Inability to provide informed consent or reliably participate in study assessments, as per the Montreal Cognitive Assessment (MOCA; score < 26) or in the opinion of the evaluating neuropsychologist.
  • Individuals unwilling or unable to undergo electrode implantation procedures
  • Medical contraindications to neurosurgery or for general anesthesia, neurosurgery, or an MRI scan (required for electrode implantation)
  • Neurological disorder other than epilepsy or other significant brain pathology, if contraindicated in the opinion of implanting neurosurgeon.
  • Women who are pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Value-manipulation
Participants with epilepsy will complete a behavioral task in which they use a laptop computer to do a decision-making and memory task.
Behavioral: Value-manipulation
During the decision-making task, different choices are assigned different values probabilistically.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Local-field potentials changes
Time Frame: During task participation, approx. 30-45 min in the first 2 weeks of hospital stay
Detection of local-field potentials (LFPs) in the various regions (hippocampus, amygdala, and frontal cortex). Local field potentials are the biological voltages recorded by macroelectrodes implanted in participant's subcortical regions as part of their treatment for epilepsy. LFP changes (measured as increases or decreases in voltage) as a function of participant behavior will be recorded, and in response to the task manipulation of the value of choices during the decision-making task
During task participation, approx. 30-45 min in the first 2 weeks of hospital stay
Firing rate changes
Time Frame: During task participation, approx. 30-45 min in the first 2 weeks of hospital stay
Single-neuron activity recorded from the hippocampus, amygdala, and frontal cortex. Single-neuron activity refers the micro-scale changes in single-neuron action potentials recorded by microelectrodes implanted in subcortical regions. Firing rate changes (measured as difference in spikes/seconds [Hz]) will be reported for neurons as a function of how behavior changes when the value of choices is altered.
During task participation, approx. 30-45 min in the first 2 weeks of hospital stay

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reaction time
Time Frame: During task participation, approx. 30-45 min in the first 2 weeks of hospital stay
Reaction times involve measuring how quickly the participant makes each choice during the decision-making and memory tasks, in milliseconds. This will be recorded by logging keypresses and mouse inputs to the behavioral computers. Slow reaction times indicate increased cognitive processing.
During task participation, approx. 30-45 min in the first 2 weeks of hospital stay
Number of hit rates for decision-making
Time Frame: During task participation, approx. 30-45 min in the first 2 weeks of hospital stay
Choices in decision-making task involved logging the decision-making selections that participants make. This will be recorded by logging keypresses and mouse inputs (left or right) to the behavioral computers. This will be used to track whether participants decisions change when value manipulations occur.
During task participation, approx. 30-45 min in the first 2 weeks of hospital stay
Number of hit rates for Memory performance
Time Frame: During task participation, approx. 30-45 min in the first 2 weeks of hospital stay
Memory performance involved logging the memory-recognition selections that participants make. This will be recorded by logging keypresses and mouse inputs (old or new) to the behavioral computers. This will be used to track whether participants memory performance changes when value manipulations occur.
During task participation, approx. 30-45 min in the first 2 weeks of hospital stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rutgers, The State University of New Jersey

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Salman E Qasim, PhD, Icahn School of Medicine at Mt. Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro2024002100
  • K99MH132873 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Access to the raw, de-identified behavioral and neural data will be limited to qualified researchers due to the potential for misuse of participant demographic and neural data within 12 months following article publication. Datasets generated by this project will be made available through the National Institute of Mental Health Data Archive (NDA).

IPD Sharing Time Frame

Within 12 months following article publication

IPD Sharing Access Criteria

The datasets will be hosted and available free of charge to approved researchers.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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