Study of Direct Brain Recording and Stimulation for Memory Enhancement

NCT04095026 | Enrolling By Invitation

• 2 other identifiers: 15008115-N-0081
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Epilepsy is a seizure disorder. Sometimes it is treated with surgery. During surgery, electrodes are placed on or in the brain. Researchers want to learn more about memory and the brain. They want to do tests on people who are having epilepsy surgery. Objective: \- To learn more about memory and brain function by recording brain cell activity during memory tasks. Eligibility: \- Adults age 18 - 65 who have medically intractable epilepsy and will have electrodes placed to identify the source of their seizures. They must be currently enrolled in protocol 11-N-0051. Design:

• Participants may do memory tests before the electrodes are put in, while they are in place, and after surgery. Researchers may stimulate areas of the brain with small pulses of electricity.
• Researchers will start recording brain activity at least 12 hours after electrodes are placed. They will record while participants are awake and asleep. They will record before, during, and after seizures.
• Participants may have up to 3 testing sessions daily over the 1-3 weeks the electrodes are in place. Each session will last 20-60 minutes.
• Participants will play games on a laptop. Sometimes they may use a button or joystick. This can be done in bed in the hospital.
• Participants may be given a list of words and asked to recall them in a short time.
• Participants may be given pairs of items and asked to remember how they are related.
• Participants may be asked to learn their way around a virtual town on the computer. Their eye movements may be tracked by a small camera.

Conditions

Epilepsy

Keywords

Epilepsy; Cognitive Function; Memory; Seizures; Surgery; Natural History

Outcome Measures

Primary Outcomes (2)

• to identify biomarkers of successful memory encoding and retrieval

  We will compare brain recordings during memory encoding for items that are later recalled versus items that are not later recalled. For example, broadband oscillatory activity from electrodes in human temporal lobe has been shown to predict which items are later recalled

  during visits/hospitalizations for 11-N-0051

• to identify brain regions that can be stimulated to enhance memory performance

  We will correlate task performance across a variety of memory tasks and electrode locations with stimulation parameters (e.g. frequency and amplitude), to identify those brain areas and stimulation parameters that increase task performance.

  during visits/hospitalizations for 11-N-0051

Secondary Outcomes (1)

• to identify biomarkers that can be used to predict cognitive impairment following resection surgery

  Ongoing

Study Arms (1)

Patients

Patients age \>18 years and \<= 65 years enrolled in 11-N-0051 Epilepsy Surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are considered for this protocol are those with medically intractable epilepsy and currently enrolled in 11-N-0051 Epilepsy Surgery. The patient population for this study is restricted to patients with medically intractable epilepsy because they require surgery for their condition. All participants in this study will require invasive monitoring as part of a clinical evaluation that may lead to subsequent resection of an epileptogenic focus. Enrollment will be equitable among those individuals who meet the inclusion criteria and will not be based on race, ethnicity, or gender.

You may qualify if:

• To be eligible for entry into the study, candidates must meet all the following criteria:
• Be enrolled in 11-N-0051 Epilepsy Surgery.
• Able to give informed consent.
• Age greater than or equal to 18 years and less than or equal to 65 years

You may not qualify if:

• Candidates will be excluded if they:
• Have any disability that would limit their ability to perform study tasks that examine memory function.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kareem A Zaghloul, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2019
• First Posted: September 19, 2019
• Study Start: October 28, 2016
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05-20

Locations

US (1)