The Computational and Neural Mechanisms Linking Decision-making and Memory in Humans
2 other identifiers
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2023
CompletedFirst Posted
Study publicly available on registry
October 10, 2023
CompletedStudy Start
First participant enrolled
October 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
December 17, 2025
December 1, 2025
4.8 years
October 2, 2023
December 15, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Local-field potentials changes
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
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 Outcomes (3)
Reaction time
During task participation, approx. 30-45 min in the first 2 weeks of hospital stay
Number of hit rates for decision-making
During task participation, approx. 30-45 min in the first 2 weeks of hospital stay
Number of hit rates for Memory performance
During task participation, approx. 30-45 min in the first 2 weeks of hospital stay
Study Arms (1)
Value-manipulation
EXPERIMENTALParticipants with epilepsy will complete a behavioral task in which they use a laptop computer to do a decision-making and memory task.
Interventions
During the decision-making task, different choices are assigned different values probabilistically.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Salman E Qasim, PhD
Icahn School of Medicine at Mt. Sinai
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 2, 2023
First Posted
October 10, 2023
Study Start
October 31, 2023
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
December 17, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Within 12 months following article publication
- Access Criteria
- The datasets will be hosted and available free of charge to approved researchers.
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).