Clinical trial NCT06072378: The Computational and Neural Mechanisms Linking Decision-making and Memory in Humans
Official title: The Computational and Neural Mechanisms Linking Decision-making and Memory in Humans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Memory, Short-Term
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-10-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Local-field potentials changes
timeFrame: During task participation, approx. 30-45 min in the first 2 weeks of hospital stay
measure: Firing rate changes
timeFrame: During task participation, approx. 30-45 min in the first 2 weeks of hospital stay
Secondary outcomes:
measure: Reaction time
timeFrame: During task participation, approx. 30-45 min in the first 2 weeks of hospital stay
measure: Number of hit rates for decision-making
timeFrame: During task participation, approx. 30-45 min in the first 2 weeks of hospital stay
measure: Number of hit rates for Memory performance
timeFrame: During task participation, approx. 30-45 min in the first 2 weeks of hospital stay
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai West
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mt. Sinai
name: Salman E Qasim, PhD
role: PRINCIPAL_INVESTIGATOR
References: