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.

Study Overview

• Status: Completed
• Conditions: Epilepsy

Detailed Description

This is a protocol to perform research studies on tissues that are removed in the operating room during surgical procedures for drug resistant epilepsy. Our aim is to acquire and supply useful tissue specimens for intramural NIH research projects.

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.

• Study Type: Observational
• Enrollment (Actual): 131

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The participant population for this study is restricted to participants with drug resistant epilepsy because they require surgery for their condition. Because the research objective is to obtain specimens for neuroscience research, only participants who require a surgical procedure that requires a craniotomy and removal of brain tissue will be included.

Description

• 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. 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:

Candidates will be excluded if they:

1. Are not a surgical candidate as specified in appropriate protocols.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients; Patients who have agreed to undergo brain surgery to treat drug resistant epilepsy and are enrolled in protocol 11-N-0051 Epilepsy Surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sample Collection	The goal of this protocol is to distribute human brain tissue samples to NINDS labs and collaborators.	Baseline

Collaborators and Investigators

• Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Kareem A Zaghloul, M.D., National Institute of Neurological Disorders and Stroke (NINDS)

Publications and helpful links

General Publications

• 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.

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start: October 10, 2001

Study Registration Dates

• First Submitted: October 11, 2001
• First Submitted That Met QC Criteria: October 11, 2001
• First Posted (Estimated): October 12, 2001

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 20, 2024
• Last Verified: April 18, 2024

More Information

Terms related to this study

• Keywords: Epilepsy; Natural History; Intractable Epilepsy; Endothelial Cells; Cell Culture; Serotonin Receptor; Temporal Lobe; Superficial Temporal Artery
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 020014; 02-N-0014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No