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Protocol Details

Surgery as a Treatment for Medically Intractable Epilepsy

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

11-N-0051

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 8
Max Age: 100

Referral Letter Required

No

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Neurosurgery;
Childhood Epilepsy;
Epilepsy;
Frontal Lobe Epilepsy;
Temporal Lobe Epilepsy

Recruitment Keyword(s)

Epilepsy

Condition(s)

Epilepsy;
Epilepsy, Temporal Lobe;
Partial Epilepsy

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and Stroke

Background:

- Medically intractable epilepsy is the term used to describe epilepsy that cannot be controlled by medication. Many people whose seizures do not respond to medication will respond to surgical treatment, relieving seizures completely or almost completely in one-half to two-thirds of patients who qualify for surgery. The tests and surgery performed as part of this treatment are not experimental, but researchers are interested in training more neurologists and neurosurgeons in epilepsy surgery and care in order to better understand epilepsy and its treatment.

Objectives:

- To use surgery as a treatment for medically intractable epilepsy in children and adults.

Eligibility:

- Children and adults at least 8 years of age who have simple or complex partial seizures (seizures that come from one area of the brain) that have not responded to medication, and who are willing to have brain surgery to treat their medically intractable epilepsy.

Design:

- Participants will be screened with a medical history, physical examination, and neurological examination. Imaging studies, including magnetic resonance imaging and computer-assisted tomography (CT), may also be conducted as part of the screening. Participants who do not need surgery or whose epilepsy cannot be treated surgically will follow up with a primary care physician or neurologist and will not need to return to the National Institutes of Health for this study.

- Prior to the surgery, participants will have the following procedures to provide information on the correct surgical approach.

- Video electroencephalography monitoring to measure brain activity during normal activities within a 24-hour period. Three to four 15-minute breaks are allowed within this period.

- Wada test to evaluate speech, comprehension, and memory centers of the brain, using a contrast dye to study the blood vessels of the brain and a short-term anesthetic administration procedure to test the effects on areas of speech and memory.

- Depth electrodes and/or brain surface electrodes to measure brain activities and determine the part of the brain that is responsible for the seizures (seizure focus).

- Participants will have a surgical procedure at the site of their seizure focus. Brain lesions, abnormal blood vessels, tumors, infections, or other areas of brain abnormality will be either removed or treated in a way that will stop or help prevent the spread of seizures without affecting irreplaceable brain functions, such as the ability to speak, understand, move, feel, or see.

- Participants will return for outpatient visits and brain imaging studies 2 months, 1 year, and 2 years after surgery.

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Eligibility

INCLUSION CRITERIA:

To be eligible for entry into the study, candidates must meet all the following criteria:

1. Be 8 years of age or older with drug resistant epilepsy or tumor related epilepsy.

2. Have focal onset seizures.

3. Seizures must persist despite medical therapy (drug resistant epilepsy) or seizures must be associated with the presence of a brain tumor.

4. Able to give informed consent, or have a parent able to provide informed consent if a child.

5. Agree to undergo brain surgery if indicated to treat drug resistant epilepsy.

EXCLUSION CRITERIA:

Candidates will be excluded if they:

1. Are pregnant (subjects of childbearing age will be tested with a urine pregnancy test and will have agreed to avoid being pregnant by practicing a reliable form of contraception or by abstinence from sexual intercourse while undergoing evaluation for epilepsy surgery and for 1 month after epilepsy surgery).

2. Cannot have an MRI scan.

3. Have a bleeding disorder that cannot be corrected before invasive testing or surgery, or other medical conditions which would make testing or surgery unsafe, such as lung or cardiac disease which would increase the risk of general anesthesia or severe immunodeficiency or systemic cancer not related to a brain lesion.


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Citations:

Sperling MR, Feldman H, Kinman J, Liporace JD, O'Connor MJ. Seizure control and mortality in epilepsy. Ann Neurol. 1999 Jul;46(1):45-50.

Jobst BC, Siegel AM, Thadani VM, Roberts DW, Rhodes HC, Williamson PD. Intractable seizures of frontal lobe origin: clinical characteristics, localizing signs, and results of surgery. Epilepsia. 2000 Sep;41(9):1139-52.

Mosewich RK, So EL, O'Brien TJ, Cascino GD, Sharbrough FW, Marsh WR, Meyer FB, Jack CR, O'Brien PC. Factors predictive of the outcome of frontal lobe epilepsy surgery. Epilepsia. 2000 Jul;41(7):843-9.

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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)



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
Not Listed
SNBrecruiting@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

Clinical Trials Number:

NCT01273129

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