NCT06489561

Brief Summary

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.

Trial Health

75
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
26mo left

Started Aug 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress56%
Aug 2023Jul 2028

Study Start

First participant enrolled

August 1, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 8, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

4.9 years

First QC Date

June 28, 2024

Last Update Submit

July 15, 2025

Conditions

Epilepsy Intractable

Keywords

EpilepsyDecision-makingDepth Electrode

Outcome Measures

Primary Outcomes (3)

  • Decision Making (Firing Rates)

    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)

    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)

    Timing of neuronal discharges (measured in spike rates per second) across the frontal lobes during a decision-making process.

    5 years

Study Arms (1)

Behavioral Testing

EXPERIMENTAL

Behavioral and Neuronal Recordings

Behavioral: Cedrus RB-844 response pad; Adtech Behnke-Fried micro-electrodes; Neurolynx electrophysiology system

Interventions

Cedrus RB-844 response pad; Adtech Behnke-Fried micro-electrodes; Neurolynx electrophysiology systemBEHAVIORAL

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)

Behavioral Testing

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Drug Resistant EpilepsyEpilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

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
Staff Physician III

Study Record Dates

First Submitted

June 28, 2024

First Posted

July 8, 2024

Study Start

August 1, 2023

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

July 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)