Study of Specimens Obtained During Epilepsy Surgery
|First Received Date ICMJE||October 11, 2001|
|Last Updated Date||May 6, 2015|
|Start Date ICMJE||October 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00025714 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Study of Specimens Obtained During Epilepsy Surgery|
|Official Title ICMJE||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 medically intractable epilepsy. Our aim is to 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 120 patients will be accepted in this protocol.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||120|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
To be eligible for entry into the study, candidates must meet al the following criteria:
Candidates will be excluded if they:
|Ages||4 Years and older|
|Accepts Healthy Volunteers||No|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00025714|
|Other Study ID Numbers ICMJE||020014, 02-N-0014|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||March 2015|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP