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Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00025714 |
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.
Condition |
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Epilepsy |
Study Type: | Observational |
Official Title: | Research Study of Specimens Obtained During Epilepsy Surgery |
Estimated Enrollment: | 60 |
Study Start Date: | October 2001 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
This is a protocol to perform research studies on tissues that are removed in the operating room during surgical procedures for medically intractable epilepsy. Our hypothesis is that we can acquire and supply useful tissue specimens for intramural NIH research projects.
The investigators will be free to select which patients will undergo surgery. However, the total number of patients that can be enrolled in the protocol will be restricted. This protocol is not designed to test any new treatments. Any treatment under this protocol will be based on the current standard of care for epilepsy surgery. The goal of the surgical procedure is to remove the epileptic focus. Standard procedures to be performed are 1) anterior temporal lobectomy or 2) amygdalohippocampectomy for temporal lobe epilepsy, and 3) focal cortical resection for epilepsy that arises outside the temporal lobe. 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. In this study superficial temporal artery and scalp tissue biopsies have been taken to obtain control tissue for in vitro experiments of gene expression in vascular disease and of immune-mediated alopecia. Biopsy of the superficial temporal artery and scalp is no longer performed in this protocol because a sufficient number of these specimens has already been obtained for these experiments.
Participants in this protocol will be evaluated for potential eligibility for other NINDS clinical trials as they are developed. However, they will not be required to enter any protocol and their decision to participate will be entirely voluntary. No more than 60 patients will be accepted in this protocol.
Ages Eligible for Study: | 4 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
To be eligible for entry into the study, candidates must meet al the following criteria:
EXCLUSION CRITERIA:
Candidates will be excluded if they:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 020014, 02-N-0014 |
Study First Received: | October 11, 2001 |
Last Updated: | August 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00025714 History of Changes |
Health Authority: | United States: Federal Government |
Serotonin Receptor Cell Culture Temporal Lobe Endothelial Cells Superficial Temporal Artery |
Magnetic Resonance Imaging (MRI) Epilepsy Epilepsy Intractable Epilepsy |
Epilepsy Central Nervous System Diseases Brain Diseases Serotonin |
Epilepsy Nervous System Diseases Central Nervous System Diseases Brain Diseases |