Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025714
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2001-10-11
Brief Title:
Study of Specimens Obtained During Epilepsy Surgery
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Research Study of Specimens Obtained During Epilepsy Surgery
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 ie 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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-N-0014 | None | None | None |