NCT06072378

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
28mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Oct 2023Sep 2028

First Submitted

Initial submission to the registry

October 2, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

October 31, 2023

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

4.8 years

First QC Date

October 2, 2023

Last Update Submit

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

EXPERIMENTAL

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

Interventions

During the decision-making task, different choices are assigned different values probabilistically.

Value-manipulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

Study Officials

  • Salman E Qasim, PhD

    Icahn School of Medicine at Mt. Sinai

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Salman E Qasim, PhD

CONTACT

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

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).

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.

Locations