Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 15-N-0081 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Patients age >18 years and <= 65 years enrolled in 11-N-0051 Epilepsy Surgery |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| to identify biomarkers that can be used to predict cognitive impairment following resection surgery | Ongoing |
Not provided
To be eligible for entry into the study, candidates must meet all the following criteria:
EXCLUSION CRITERIA:
Candidates will be excluded if they:
-Have any disability that would limit their ability to perform study tasks that examine memory function.
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kareem A Zaghloul, M.D. | National Institute of Neurological Disorders and Stroke (NINDS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
Not provided
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
Not provided
We do plan to share IPD. We will share all IPD that results in a publication on a public repository, as required by most journals. The data will be de-identified and anonymized.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
Not provided
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |