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Study of Direct Brain Recording and Stimulation for Memory Enhancement

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ClinicalTrials.gov Identifier: NCT04095026
Recruitment Status : Enrolling by invitation
First Posted : September 19, 2019
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Tracking Information
First Submitted Date September 14, 2019
First Posted Date September 19, 2019
Last Update Posted Date November 4, 2019
Actual Study Start Date February 4, 2015
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 18, 2019)
  • to identify biomarkers of successful memory encoding and retrieval [ Time Frame: during visits/hospitalizations for 11-N-0051 ]
    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
  • to identify brain regions that can be stimulated to enhance memory performance [ Time Frame: during visits/hospitalizations for 11-N-0051 ]
    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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT04095026 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 18, 2019)
To identify biomarkers that can be used to predict cognitive impairment following resection surgery [ Time Frame: Ongoing ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Direct Brain Recording and Stimulation for Memory Enhancement
Official Title A Study of Direct Brain Recording and Stimulation for Memory Enhancement
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Epilepsy
Intervention Not Provided
Study Groups/Cohorts Patients
Up to 100 people considering epilepsy surgery will participate at NIH.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Actual Enrollment
 (submitted: October 31, 2019)
48
Original Actual Enrollment
 (submitted: September 18, 2019)
38
Estimated Study Completion Date December 1, 2023
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04095026
Other Study ID Numbers 150081
15-N-0081
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
Study Sponsor National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators Not Provided
Investigators
Principal Investigator: Kareem A Zaghloul, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date October 29, 2019