EpilepsyNCT00025714
Study of Specimens Obtained During Epilepsy Surgery
An observational study of Epilepsy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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 i.e., epilepsy that cannot be controlled with medicine requires removal of more brain tissue than is needed for diagnostic study. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Epilepsy
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2001to 31 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- To be eligible for entry into the study, candidates must meet al the following criteria:
- Be 4 years of age or older.
- Able to give informed consent, or, assent if a child.
- Have agreed to undergo brain surgery to treat drug resistant epilepsy and are enrolled in protocol 11-N-0051 Epilepsy Surgery.
Who cannot join
- Candidates will be excluded if they:
- 1. Are not a surgical candidate as specified in appropriate protocols.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read the 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.
- Conditions
- Epilepsy
- Keywords
- Serotonin Receptor, Cell Culture, Temporal Lobe, Endothelial Cells, Superficial Temporal Artery, Natural History, Epilepsy, Intractable Epilepsy
- Medical subject headings
- Epilepsy, Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Sample Collection
The goal of this protocol is to distribute human brain tissue samples to NINDS labs and collaborators.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2001 (estimated)
- Study start10 Oct 2001
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kareem A Zaghloul, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00025714
- Sponsor's protocol ID
- 020014
- Other IDs
- 02-N-0014
- Status last verified
- Jul 2024
- First submitted
- 11 Oct 2001
- Last updated
- 19 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ojemann GA. Temporal lobe epilepsy. Clin Neurosurg. 1997;44:79-90. No abstract available.
PubMed 10080003Sperling 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.
PubMed 10401779Yasargil 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.
PubMed 8467211
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Study of Specimens Obtained During Epilepsy Surgery
- ClinicalTrials.gov ID
- NCT00025714
- Acronym / sponsor ID
- 020014
- Conditions
- Epilepsy
- Keywords
- Serotonin Receptor, Cell Culture, Temporal Lobe, Endothelial Cells, Superficial Temporal Artery, Natural History, Epilepsy, Intractable Epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 10 Oct 2001 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 12 Oct 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients who have agreed to undergo brain surgery to treat drug resistant epilepsy and are enrolled in protocol 11-N-0051 Epilepsy Surgery. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Be 4 years of age or older.
- Able to give informed consent, or, assent if a child.
- Have agreed to undergo brain surgery to treat drug resistant epilepsy and are enrolled in protocol 11-N-0051 Epilepsy Surgery.
Key exclusion criteria (2 listed)
- 1. Are not a surgical candidate as specified in appropriate protocols.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sample Collection
Time frame: Baseline
The goal of this protocol is to distribute human brain tissue samples to NINDS labs and collaborators.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Background: PubMed 10080003Ojemann GA. Temporal lobe epilepsy. Clin Neurosurg. 1997;44:79-90. No abstract available.
- Background: PubMed 10401779Sperling 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.
- Background: PubMed 8467211Yasargil 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kareem A Zaghloul, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sample Collection (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00025714, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.