Study of Specimens Obtained During Epilepsy Surgery

This study is currently recruiting participants.
Verified June 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00025714
First received: October 11, 2001
Last updated: March 14, 2014
Last verified: June 2013

October 11, 2001
March 14, 2014
October 2001
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Complete list of historical versions of study NCT00025714 on ClinicalTrials.gov Archive Site
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Study of Specimens Obtained During Epilepsy Surgery
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.

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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.

Observational
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Epilepsy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
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  • 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.
Both
4 Years and older
No
Contact: Gretchen C Scott, R.N. Not Listed SNBrecruiting@nih.gov
United States
 
NCT00025714
020014, 02-N-0014
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National Institute of Neurological Disorders and Stroke (NINDS)
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Principal Investigator: Kareem A Zaghloul, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health Clinical Center (CC)
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP