EpilepsyNCT00152659
Developing Criteria for Cortical Resections
An observational study of Epilepsy and Tumor, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to study how disease processes like tumors or epilepsy spread in the brain. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Tissue sample (procedure/screening)
- Type of treatment
- Surgery or procedure
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 1998to 14 Nov 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Surgical candidates with epilepsy or brain tumor(s)
Who may be able to join
- Surgical candidates with epilepsy or brain tumor(s)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago Hospitals, The University of Chicago Comer Children's Hospital
Chicago, Illinois, 60637
About this study
Official title: Developing Functional and Structural Criteria for Cortical Resections
The purpose of this study is to study how disease processes like tumors or epilepsy spread in the brain.
Read the detailed description
The purpose of this study is to study how disease processes like tumors or epilepsy spread in the brain. During surgery small pieces of abnormal (unusual) brain tissue may be removed. We analyze these specimens using more advanced microscopic and electrophysiologic techniques than are usually applied to such tissue specimens. In addition, some tissues can be maintained in laboratory conditions to allow analysis over the longer term. No extra brain tissue is taken to perform these studies. The tissue analysis is performed by the research team and are compared to the routine (normal) electrical recordings that are taken during this type of brain surgery. Currently there are no instructions telling a doctor how much brain tissue should be cut out to prevent the spread of tumors or epilepsy. We are hoping that the results of this study help us to better know how much brain tissue needs to be removed to prevent the spread of tumors or epilepsy.
- Being tested
- Tissue sample (procedure/screening)
- Keywords
- Epilepsy, Tumor, Surgery, Brain
- Medical subject headings
- Epilepsy, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue sample (procedure/screening)Procedure or surgery
Tissue sampling
What is being measured
The primary outcome is the main question the study is designed to answer.
measure electrical activity in tissue sample
Measured: at tissue aremoval time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study start1 Sep 1998
- Primary completion14 Nov 2022
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wim van Drongelen, Ph.D., Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152659
- Sponsor's protocol ID
- 9538
- Status last verified
- Apr 2023
- First submitted
- 7 Sep 2005
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Ramirez J-M, Koch H, Pena F, Drongelen W van, Tryba AK, Parkis MA, Loweth JA, Hecox KE, Kohrman MH, Frim DM, Chico MS, Marcuccilli CJ (2003) - In vitro electrophysiological differences between least and most abnormal tissue obtained from pediatric patients with intractable epilepsy. Epilepsia 44, Suppl 9: 245-246
Marcuccilli CJ, Koch H, Pena F, Drongelen W van, Tryba AK, Parkis MA, Hecox KE, Kohrman MH, Frim DM, OConnor SE, Chico MS, Ramirez J-M (2003) - Rational pharmacotherapy: relationship between in vitro electrophysiology and clinical measures. Epilepsia 44, Suppl 9: 244-245
Drongelen W van, Koch H, Marcuccilli CJ, Viemari J, Tryba AKH, Loweth JA, Ramirez J-M, Elsen F (2004) - Persistent sodium current plays a critical role in the generation of slow oscillations in vitro neocortex brain slices of mice and humans. Abstract Soc Neuroscience
Drongelen W van, Doren EL, Koch H, Marcuccilli CJ, Ramirez J-M, Elsen FP (2005) - Characterization of the persistent sodium current in neocortical networks of mice and humans. Abstract Washington DC: Society for Neuroscience
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Functional and Structural Criteria for Cortical Resections
- ClinicalTrials.gov ID
- NCT00152659
- Acronym / sponsor ID
- 9538
- Keywords
- Epilepsy, Tumor, Surgery, Brain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Sep 1998 (actual)
- Primary completion
- 14 Nov 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 9 Sep 2005 (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.
The purpose of this study is to study how disease processes like tumors or epilepsy spread in the brain.
Detailed description
The purpose of this study is to study how disease processes like tumors or epilepsy spread in the brain. During surgery small pieces of abnormal (unusual) brain tissue may be removed. We analyze these specimens using more advanced microscopic and electrophysiologic techniques than are usually applied to such tissue specimens. In addition, some tissues can be maintained in laboratory conditions to allow analysis over the longer term. No extra brain tissue is taken to perform these studies. The tissue analysis is performed by the research team and are compared to the routine (normal) electrical recordings that are taken during this type of brain surgery. Currently there are no instructions telling a doctor how much brain tissue should be cut out to prevent the spread of tumors or epilepsy. We are hoping that the results of this study help us to better know how much brain tissue needs to be removed to prevent the spread of tumors or epilepsy.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Surgical candidates with epilepsy or brain tumor(s)
Key inclusion criteria (1 listed)
- Surgical candidates with epilepsy or brain tumor(s)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue sample (procedure/screening)Tissue sampling | Procedure or surgery | – |
Primary outcome
measure electrical activity in tissue sample
Time frame: at tissue aremoval time
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 26 Apr 2023.
- BackgroundRamirez J-M, Koch H, Pena F, Drongelen W van, Tryba AK, Parkis MA, Loweth JA, Hecox KE, Kohrman MH, Frim DM, Chico MS, Marcuccilli CJ (2003) - In vitro electrophysiological differences between least and most abnormal tissue obtained from pediatric patients with intractable epilepsy. Epilepsia 44, Suppl 9: 245-246
- BackgroundMarcuccilli CJ, Koch H, Pena F, Drongelen W van, Tryba AK, Parkis MA, Hecox KE, Kohrman MH, Frim DM, OConnor SE, Chico MS, Ramirez J-M (2003) - Rational pharmacotherapy: relationship between in vitro electrophysiology and clinical measures. Epilepsia 44, Suppl 9: 244-245
- BackgroundDrongelen W van, Koch H, Marcuccilli CJ, Viemari J, Tryba AKH, Loweth JA, Ramirez J-M, Elsen F (2004) - Persistent sodium current plays a critical role in the generation of slow oscillations in vitro neocortex brain slices of mice and humans. Abstract Soc Neuroscience
- BackgroundDrongelen W van, Doren EL, Koch H, Marcuccilli CJ, Ramirez J-M, Elsen FP (2005) - Characterization of the persistent sodium current in neocortical networks of mice and humans. Abstract Washington DC: Society for Neuroscience
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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.
Wim van Drongelen, Ph.D. principal investigator
University of Chicago
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 and Tumor, run by University of Chicago 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 1 inclusion and 0 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 26 Apr 2023. 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?
measure electrical activity in tissue sample (time frame: at tissue aremoval time). 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 NCT00152659, which also lists 4 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 26 Apr 2023; AzTrials last refreshed its copy on 28 Oct 2026.