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

Memory, Short-Term Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06072378
• Other study ID #: GCO 22-1028
• Secondary ID: K99MH132873
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2023
• Est. completion date: August 2025

Study information

• Verified date: November 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Salman E Qasim, PhD
• Phone: 212-824-9531
• Email: salman.qasim[@]mssm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Memory, Short-Term

Intervention

Behavioral:
• Value-manipulation
During the decision-making task, different choices are assigned different values probabilistically.

Locations

Country	Name	City	State
United States	Mount Sinai West	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Reaction time	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
Secondary	Number of hit rates for decision-making	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
Secondary	Number of hit rates for Memory performance	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