NCT04500119

Brief Summary

The purpose the research is to better understand how the human brain accomplishes the basic cognitive tasks of learning new information, recalling stored information, and making decisions or choices about presented information. These investigations are critical to better understand human cognition and to design treatments for disorders of learning and memory.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Aug 2020

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 Progress96%
Aug 2020Jul 2026

First Submitted

Initial submission to the registry

July 29, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

August 12, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

February 9, 2026

Status Verified

January 1, 2026

Enrollment Period

6 years

First QC Date

July 29, 2020

Last Update Submit

February 5, 2026

Conditions

Epilepsy Intractable

Keywords

EpilepsyDecision-makingMemoryDepth Electrode

Outcome Measures

Primary Outcomes (7)

  • Persistent Neuronal Activity (Firing Rates)

    Neuronal firing rates (measured in spike rates per second) of cells in the frontal and temporal lobes during working memory.

    3 years

  • Persistent Neuronal Activity (Power)

    Power of local field potential bandwidths (measured in amplitude across frequency of the bandwidths) in the frontal and temporal lobes during working memory.

    3 years

  • Decision Making (Firing Rates)

    Neuronal firing rates of cells (measured in spike rates per second) in the frontal and temporal 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 and temporal lobes during a decision-making process.

    5 years

  • Decision Making (Timing)

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

    5 years

  • Disruption of learning and memory via electrical stimulation (firing rates)

    Measure the change in firing rates of neurons (measured in amplitude across frequency of the bandwidths) after applying small pulse of electrical activity during a learning task.

    5 years

  • Disruption of learning and memory via electrical stimulation (memory)

    Measure the change in memory (measured in spike rates per second) observed after applying small pulse of electrical activity during a learning task.

    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; Blackrock Cerestim stimulator

Interventions

Cedrus RB-844 response pad; Adtech Behnke-Fried micro-electrodes; Neurolynx electrophysiology system; Blackrock Cerestim stimulatorBEHAVIORAL

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), apply intermittent electrical stimulation (Blackrock Cerestim)

Behavioral Testing

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (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

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
Professor of Neurosurgery

Study Record Dates

First Submitted

July 29, 2020

First Posted

August 5, 2020

Study Start

August 12, 2020

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

February 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)