Neural Computations of Goal-directed Decision-making

July 15, 2025 updated by: Adam Mamelak, MD, Cedars-Sinai Medical Center

Probing the Neural Computations Underlying Goal-directed Decision-making in Humans With Single-neuron Recordings

The purpose of this research is to better understand how the human brain accomplishes the cognitive task of making goal-directed decisions. These investigations are critical to better understand human cognition and to design treatments for disorders of decision making and performance monitoring.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Flexible goal-directed decision-making is a core aspect of higher-order adaptive biological intelligence. A number of psychiatric disorders involve impairments in goal-directed decision-making, yet the current lack of even a basic understanding of how goal-directed action selection is implemented at the neuronal level in humans hinders the ability to pinpoint these neuropsychiatric dysfunctions. In particular, it is completely unknown how goals, and the stimuli and actions that need to be selected from in order to pursue them, are represented at the level of single neurons, nor how goals get selected from available possible goals.

The study experiments utilize the rare opportunity to record in-vivo from human single neurons simultaneously in multiple brain areas in patients undergoing treatment for drug resistant epilepsy. The study will utilize a combination of (i) in-vivo recordings in awake behaving humans assessing decision making accuracy and ability through choice ratings, (ii) computational analysis and modeling.

These techniques will be applied to characterize the functional contribution of human ventromedial prefrontal (vmPFC), dorsal anterior cingulate (dACC) and pre-supplementary motor area (pre-SMA) in these processes. Investigators will first test the longstanding proposal never tested at the neuronal level in humans that the value of stimuli is especially represented by neurons in vmPFC, while the value of actions are more represented by neurons in dorsal cortical areas such as the pre-SMA. Investigators will then address how goals themselves are represented. In the real world, animals including humans need to select a goal before any action is performed. Thus, there is a hierarchical process of goal selection followed by action selection. Investigators hypothesize that the vmPFC plays a specific role in goal-valuation and selection, while neurons in dorsomedial areas including pre-SMA and dACC will play more of a role in valuing and selecting the actions that implement the chosen goal.

The expected outcome of this work is a comprehensive understanding of the functions of the human PFC in goal-directed decision-making at cellular resolution while shedding light on the neural mechanisms of goal-representation and selection which hitherto has been virtually unstudied.

Study Type

Interventional

Enrollment (Estimated)

50

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 Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

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:

  • Intractable epilepsy, undergoing invasive monitoring
  • Age ≥13
  • Full Scale Intelligence Quotient > 70
  • Ability to comprehend and perform simple behavioral tasks by pressing buttons on laptop computer in response to questions

Exclusion Criteria:

  • Determination by clinicians and investigators that a patient is unable to complete the behavioral tasks required for the protocol due to either cognitive limits, psychological limits, or pain

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: Behavioral Testing
Behavioral and Neuronal Recordings
Behavioral: Cedrus RB-844 response pad; Adtech Behnke-Fried micro-electrodes; Neurolynx electrophysiology system
Devices listed are components of a single intervention that includes: Record patient responses (Cedrus RB-844), record neuronal activity (Neurolynx) from electrodes (Adtech Behnke-Fried)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decision Making (Firing Rates)
Time Frame: 5 years
Neuronal firing rates of cells (measured in spike rates per second) in the frontal lobes during a decision-making process.
5 years
Decision Making (Power)
Time Frame: 5 years
Power of local field potential bandwidths (measured in amplitude across frequency of the bandwidths) in the frontal lobes during a decision-making process.
5 years
Decision Making (Timing)
Time Frame: 5 years
Timing of neuronal discharges (measured in spike rates per second) across the frontal lobes during a decision-making process.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Collaborators

National Institute of Mental Health (NIMH)
California Institute of Technology

Investigators

  • Principal Investigator: Ueli Rutishauser, PhD, Cedars-Sinai Medical Center
  • Principal Investigator: Adam Mamelak, MD, Cedars-Sinai Medical Center
  • Principal Investigator: John O'Doherty, PhD, California Institute of Technology

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)

August 1, 2023

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

June 28, 2024

First Submitted That Met QC Criteria

June 28, 2024

First Posted (Actual)

July 8, 2024

Study Record Updates

Last Update Posted (Actual)

July 18, 2025

Last Update Submitted That Met QC Criteria

July 15, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOD00001351
  • R01MH133729 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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