Study of Specimens Obtained During Epilepsy Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: June 18, 2014
Last verified: May 2014
  Purpose

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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Condition
Epilepsy

Study Type: Observational
Official Title: Research Study of Specimens Obtained During Epilepsy Surgery

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 120
Study Start Date: October 2001
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00025714

Contacts
Contact: Gretchen C Scott, R.N. Not Listed SNBrecruiting@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Kareem A Zaghloul, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00025714     History of Changes
Other Study ID Numbers: 020014, 02-N-0014
Study First Received: October 11, 2001
Last Updated: June 18, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Serotonin Receptor
Cell Culture
Temporal Lobe
Endothelial Cells
Superficial Temporal Artery
Magnetic Resonance Imaging (MRI)
Epilepsy
Intractable Epilepsy

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 19, 2014