- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06072378
The Computational and Neural Mechanisms Linking Decision-making and Memory in Humans
November 13, 2023 updated by: Salman E Qasim, Icahn School of Medicine at Mount Sinai
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
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
25
Phase
- 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
- Name: Salman E Qasim, PhD
- Phone Number: 212-824-9531
- Email: salman.qasim@mssm.edu
Study Locations
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New York
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New York, New York, United States, 10024
- Recruiting
- Mount Sinai West
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Principal Investigator:
- Salman E Qasim
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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
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 |
Intervention / Treatment |
---|---|
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.
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During the decision-making task, different choices are assigned different values probabilistically.
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What is the study measuring?
Primary Outcome Measures
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
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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
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During task participation, approx. 30-45 min in the first 2 weeks of hospital stay
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Firing rate changes
Time Frame: During task participation, approx. 30-45 min in the first 2 weeks of hospital stay
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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.
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During task participation, approx. 30-45 min in the first 2 weeks of hospital stay
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Secondary Outcome Measures
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.
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During task participation, approx. 30-45 min in the first 2 weeks of hospital stay
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Number of hit rates for decision-making
Time Frame: During task participation, approx. 30-45 min in the first 2 weeks of hospital stay
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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.
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During task participation, approx. 30-45 min in the first 2 weeks of hospital stay
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Number of hit rates for Memory performance
Time Frame: During task participation, approx. 30-45 min in the first 2 weeks of hospital stay
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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.
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During task participation, approx. 30-45 min in the first 2 weeks of hospital stay
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- 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)
October 31, 2023
Primary Completion (Estimated)
August 1, 2025
Study Completion (Estimated)
August 1, 2025
Study Registration Dates
First Submitted
October 2, 2023
First Submitted That Met QC Criteria
October 2, 2023
First Posted (Actual)
October 10, 2023
Study Record Updates
Last Update Posted (Actual)
November 15, 2023
Last Update Submitted That Met QC Criteria
November 13, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- GCO 22-1028
- 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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