Study of Direct Brain Recording and Stimulation for Memory Enhancement

NCT ID: NCT04095026

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-28
• Study Completion Date: 2027-01-01

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.

Detailed Description

Objective

The primary objectives of this study are (1) to identify biomarkers of successful memory encoding and retrieval, and (2) to identify brain regions that can be stimulated to affect memory performance. The secondary objective is to identify biomarkers that can be used to predict cognitive impairment following resection surgery.

Study Population

One hundred (100) adult subjects with epilepsy who are enrolled in 11-N-0051 Epilepsy Surgery protocol.

Study Design

We plan to enroll individuals with drug resistant epilepsy who are enrolled in a separate protocol, 11-N-0051 Epilepsy Surgery, and who will undergo a neurosurgical procedure in which seizure activity and cognitive functions are mapped using intracranial electrodes in order to guide resection of seizure generating tissue. In this procedure, surgeons place electrodes solely based on clinical consideration with the goal of identifying the seizure focus (or foci) and also for purposes of functional mapping using electrical stimulation.

We propose to administer computerized memory tasks during the intracranial EEG monitoring period. Memory testing may also occur during other patient visits for protocol 11-N-0051. This testing may occur during a pre-surgical outpatient visit or during Phase 1 (pre-implantation) monitoring, to establish baseline memory performance, or after the resection surgery, to identify potential changes in memory performance due to the resection. All testing associated with this protocol will be done during visits or hospitalizations for 11-N-0051, and this protocol involves no additional study visits.

Some memory test sessions will include low-intensity electrical stimulation of the brain using the intracranial electrodes. During these sessions, brain stimulation trials will be interleaved with non- stimulation trials in a randomized fashion.

EEG recordings will be retrospectively analyzed for the presence of biomarkers that correlate with successful memory performance, and test performance will be compared between the stimulation and no-stimulation conditions.

The studies described here are voluntary and for research purpose only. They will not interfere with the clinical evaluation or decision-making process for epilepsy surgery.

Outcome Measures

The primary outcomes are (1) to identify biomarkers of successful memory encoding and retrieval, and (2) to identify brain regions that can be stimulated to affect memory performance. The secondary outcome is to identify biomarkers that can be used to predict cognitive impairment following resection surgery.

Conditions

Epilepsy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Candidates will be excluded if they:

-Have any disability that would limit their ability to perform study tasks that examine memory function.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kareem A Zaghloul, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Institute of Neurological Disorders and Stroke (NINDS)

Locations

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Countries

United States

Related Links

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2015-N-0081.html

NIH Clinical Center Detailed Web Page

Other Identifiers

15-N-0081

Identifier Type: -

Identifier Source: secondary_id

150081

Identifier Type: -

Identifier Source: org_study_id