Study of Specimens Obtained During Epilepsy Surgery



Status:Recruiting
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:4 - Any
Updated:1/9/2019
Start Date:October 10, 2001
Contact:Aaliyah H Thiam
Email:SNBrecruiting@nih.gov
Phone:Not Listed

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Research Study of Specimens Obtained During Epilepsy Surgery

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.

This is a protocol to perform research studies on tissues that are removed in the operating
room during surgical procedures for drug resistant epilepsy. Our aim is to acquire and supply
useful tissue specimens for intramural NIH research projects.

The investigators will evaluate participants with medically intractable drug resistant
epilepsy who are considered for surgery to determine whether surgical specimen may be
available for this protocol. Surgery and standard care for these participants will be
performed under a separate protocol, 11-N-0051 Epilepsy Surgery. The intent of this protocol
is solely for procuring tissue that is resected for standard clinical care during surgery.
This protocol is not designed to test any new treatments.

These are the research aspects of the protocol: 1) Any brain tissue that is removed and is
not required for diagnostic studies will be used for laboratory studies, consistent with
institutional guidelines. 2) Blood tests to test for immune and inflammatory mediators will
be performed. 3) Saliva will be collected to test for immune and inflammatory markers.

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

3. Have agreed to undergo brain surgery to treat drug resistant epilepsy and are enrolled
in protocol 11-N-0051 Epilepsy Surgery.

EXCLUSION CRITERIA:

Candidates will be excluded if they:

1. Are not a surgical candidate as specified in appropriate protocols.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Phone: 800-411-1222
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Bethesda, MD
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