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Protocol Details

An Investigator-Initiated, Prospective, Multi-Center, Controlled Feasibility Study of Direct Brain Recording and Stimulation for Memory Enhancement

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

15-N-0081

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Enrolling by Invitation
Gender: Male & Female
Min Age: 18
Max Age: 65

Referral Letter Required

Yes

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Epilepsy;
Cognitive Function;
Memory;
Seizures;
Surgery

Recruitment Keyword(s)

None

Condition(s)

None

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

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.

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Eligibility

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.


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Citations:

Burke JF, Long NM, Zaghloul KA, Sharan AD, Sperling MR, Kahana MJ. Human intracranial high-frequency activity maps episodic memory formation in space and time. Neuroimage. 2014 Jan 15;85 Pt 2:834-43. doi: 10.1016/j.neuroimage.2013.06.067. Epub 2013 Jul 1.

Suthana N, Haneef Z, Stern J, Mukamel R, Behnke E, Knowlton B, Fried I. Memory enhancement and deep-brain stimulation of the entorhinal area. N Engl J Med. 2012 Feb 9;366(6):502-10. doi: 10.1056/NEJMoa1107212.

Jacobs J, Lega B, Anderson C. Explaining how brain stimulation can evoke memories. J Cogn Neurosci. 2012 Mar;24(3):553-63. doi: 10.1162/jocn_a_00170. Epub 2011 Nov 18.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Kareem A. Zaghloul, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10 RM 3D20
10 CENTER DR
BETHESDA MD 20814
(301) 594-8114
zaghloulka@mail.nih.gov

Aaliyah H. Hamidullah-Thiam
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 7-5680
10 Center Drive
Bethesda, Maryland 20892
(301) 496-5121
aaliyah.hamidullahthiam@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

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