Memory Retrieval and Encoding Investigated by Neural Stimulation

NCT ID: NCT04286776

Last Updated: 2024-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-12

Study Completion Date

2024-12-31

Brief Summary

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The purpose of this research is to understand biomarkers of human memory through correlational analyses and to use focal electrical stimulation as a causal manipulation to understand how biomarkers of memory relate to other brain states and behavioral measures.

Detailed Description

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Conditions

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Epilepsy Intractable

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All enrolled patients are considered eligible to receive direct electrical stimulation. Subjects have the option to receive non stimulation testing only.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Direct Electrical Stimulation

Stimulation will be applied concurrently with the task, if applicable, and stimulation trials will be interleaved with sham trials, where no stimulation is delivered.

Group Type EXPERIMENTAL

Direct electrical stimulation

Intervention Type DEVICE

Stimulation will not exceed 0.75 mA and will be approved prior by study investigators. Each subject will have a safety threshold testing at the beginning of each session and if 'afterdischarges' occur the subject's stimulation threshold will be lowered.

Interventions

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Direct electrical stimulation

Stimulation will not exceed 0.75 mA and will be approved prior by study investigators. Each subject will have a safety threshold testing at the beginning of each session and if 'afterdischarges' occur the subject's stimulation threshold will be lowered.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Expected to undergo intracranial implantation and postoperative electroencephalographic monitoring as part of a standard clinical procedure for the treatment of pharmacologically resistant epilepsy
2. Age 18 or older

Exclusion Criteria

1. Any physical or cognitive disability or illness that would limit their ability to perform cognitive tasks
2. Any medical condition that would, in the investigator's opinion, limit the subject's participation in the study.
3. Unable or unwilling to provide informed consent
4. MRI contraindications

Standard clinical care includes a pregnancy test for female patients prior to the surgical implantation of the electrodes. Pregnant women are not surgically implanted.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Kahana, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Colorado, Denver

Aurora, Colorado, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

National Institute of Neurological Disorders and Stroke

Bethesda, Maryland, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Columbia University

New York, New York, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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Ezzyat Y, Kragel JE, Solomon EA, Lega BC, Aronson JP, Jobst BC, Gross RE, Sperling MR, Worrell GA, Sheth SA, Wanda PA, Rizzuto DS, Kahana MJ. Functional and anatomical connectivity predict brain stimulation's mnemonic effects. bioRxiv [Preprint]. 2023 Aug 11:2023.07.27.550851. doi: 10.1101/2023.07.27.550851.

Reference Type BACKGROUND
PMID: 37609181 (View on PubMed)

Ezzyat Y, Wanda PA, Levy DF, Kadel A, Aka A, Pedisich I, Sperling MR, Sharan AD, Lega BC, Burks A, Gross RE, Inman CS, Jobst BC, Gorenstein MA, Davis KA, Worrell GA, Kucewicz MT, Stein JM, Gorniak R, Das SR, Rizzuto DS, Kahana MJ. Closed-loop stimulation of temporal cortex rescues functional networks and improves memory. Nat Commun. 2018 Feb 6;9(1):365. doi: 10.1038/s41467-017-02753-0.

Reference Type BACKGROUND
PMID: 29410414 (View on PubMed)

Kragel JE, Ezzyat Y, Lega BC, Sperling MR, Worrell GA, Gross RE, Jobst BC, Sheth SA, Zaghloul KA, Stein JM, Kahana MJ. Distinct cortical systems reinstate the content and context of episodic memories. Nat Commun. 2021 Jul 21;12(1):4444. doi: 10.1038/s41467-021-24393-1.

Reference Type BACKGROUND
PMID: 34290240 (View on PubMed)

Other Identifiers

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1U01NS113198-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5R01NS106611-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

820553

Identifier Type: -

Identifier Source: org_study_id

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