Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
131 participants
OBSERVATIONAL
2001-10-10
2019-10-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Patients
Patients who have agreed to undergo brain surgery to treat drug resistant epilepsy and are enrolled in protocol 11-N-0051 Epilepsy Surgery.
No interventions assigned to this group
Eligibility Criteria
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Inclusion 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
1\. Are not a surgical candidate as specified in appropriate protocols.
4 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Responsible Party
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Principal Investigators
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Kareem A Zaghloul, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Neurological Disorders and Stroke (NINDS)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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References
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Ojemann GA. Temporal lobe epilepsy. Clin Neurosurg. 1997;44:79-90. No abstract available.
Sperling MR, Feldman H, Kinman J, Liporace JD, O'Connor MJ. Seizure control and mortality in epilepsy. Ann Neurol. 1999 Jul;46(1):45-50. doi: 10.1002/1531-8249(199907)46:13.0.co;2-i.
Yasargil MG, Wieser HG, Valavanis A, von Ammon K, Roth P. Surgery and results of selective amygdala-hippocampectomy in one hundred patients with nonlesional limbic epilepsy. Neurosurg Clin N Am. 1993 Apr;4(2):243-61. No abstract available.
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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02-N-0014
Identifier Type: -
Identifier Source: secondary_id
020014
Identifier Type: -
Identifier Source: org_study_id
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