Protocol Number: 02-N-0014

Title:

Research Study of Specimens Obtained During Epilepsy Surgery

Number:

02-N-0014

Summary:

This study will collect brain tissue samples for research purposes from patients undergoing surgery to treat epilepsy. The standard surgical procedure for medically intractable epilepsy-i.e., epilepsy that cannot be controlled with medicine-requires removal of more brain tissue than is needed for diagnostic study. This extra tissue, which would otherwise be discarded, will be used for research purposes. In addition, a blood vessel in the scalp, called the superficial temporal artery, is also normally cut during surgery, and a piece of this vessel will be taken for research use.

Patients 4 years of age or older who undergo surgery for medically intractable epilepsy may be eligible for this study.

Brain tissue collected under this protocol will be used for studies of brain cells in other diseases and of serotonin receptors. Any remaining brain tissue will be frozen for use in future research. The superficial temporal artery will be used for comparison with carotid arteries (a neck artery that supplies the brain) from patients with blockage of this blood vessel.

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

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

1. Be 4 years of age or older.

2. Have simple or complex partial seizures.

3. Seizures must persist despite medical therapy.

4. Able to give informed consent, or, assent if a child.

5. Have been determined by the NINDS neurology staff to have medically intractable epilepsy.

6. Have agreed to undergo brain surgery to treat medically intractable epilepsy.

7. Have agreed to allow some of the tissue removed during the surgery to be used for research.

EXCLUSION CRITERIA:

Candidates will be excluded if they:

1. Are pregnant. (Women 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.)

2. Cannot have an MRI scan as determined by the radiologist.

3. Have a bleeding disorder that cannot be corrected before testing or treatment.

4. Are unable to understand the risks of the testing and surgical therapy. (A clinical neuropsychologist that is not an investigator for this protocol examines all patients before epilepsy surgery. She will determine if a subject is unable to understand risks, unable to reach reasonable decisions and incompetent to give informed consent.

Special Instructions:

Currently Not Provided

Keywords:

Serotonin Receptor

Cell Culture

Temporal Lobe

Endothelial Cells

Superficial Temporal Artery

Magnetic Resonance Imaging (MRI)

Epilepsy

Recruitment Keyword(s):

Epilepsy

Intractable Epilepsy

Condition(s):

Epilepsy

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Neurological Disorders and Stroke

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Temporal lobe epilepsy

Seizure control and mortality in epilepsy

Surgery and results of selective amygdala-hippocampectomy in one hundred patients with nonlesional limbic epilepsy

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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