NCT00025714

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2001

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 11, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 12, 2001

Completed
18.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

18.1 years

First QC Date

October 11, 2001

Last Update Submit

July 18, 2024

Conditions

Epilepsy

Keywords

Serotonin ReceptorCell CultureTemporal LobeEndothelial CellsSuperficial Temporal ArteryNatural HistoryEpilepsyIntractable Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Sample Collection

    The goal of this protocol is to distribute human brain tissue samples to NINDS labs and collaborators.

    Baseline

Study Arms (1)

Patients

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

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Candidates will be excluded if they:
  • \. Are not a surgical candidate as specified in appropriate protocols.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Ojemann GA. Temporal lobe epilepsy. Clin Neurosurg. 1997;44:79-90. No abstract available.

    PMID: 10080003BACKGROUND

  • 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.

    PMID: 10401779BACKGROUND

  • 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.

    PMID: 8467211BACKGROUND

Related Links

MeSH Terms

Conditions

EpilepsyDrug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Kareem A Zaghloul, M.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2001

First Posted

October 12, 2001

Study Start

October 10, 2001

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

July 19, 2024

Record last verified: 2024-07

Locations

US(1)