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The Influence of SISCOM on Intracranial Electrode Implantation in Epilepsy Surgical Candidates

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587951
First received: December 22, 2007
Last updated: January 7, 2008
Last verified: November 2007
History of Changes

December 22, 2007
January 7, 2008
December 2005
February 2007   (final data collection date for primary outcome measure)
Category of management recommendation (proceed straight to surgical resection, intracranial electrode implantation, more imaging studies OR recommend medical rather than surgical management) [ Time Frame: Instantaneous ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00587951 on ClinicalTrials.gov Archive Site
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The Influence of SISCOM on Intracranial Electrode Implantation in Epilepsy Surgical Candidates
The Influence of SISCOM on Intracranial Electrode Implantation in Epilepsy Surgical Candidates

The aim of this study is to determine the role of SISCOM (see below) in aiding clinicians to manage epilepsy surgery candidates. SISCOM is already a routine component of pre-surgical epilepsy evaluation at Mayo Clinic. In particular, we are interested in assessing whether use of SISCOM can minimize the need for prolonged (>24 hours) invasive monitoring with electrodes placed on the surface of the brain prior to surgical resection.

Note: this study has recruited the required number of patients and is closed to further enrolment.

Successful epilepsy surgery depends on accurate identification of the area of brain from which seizures originate (the epileptogenic zone). There are many non-invasive tests (including EEG and MRI) to indicate this area. Some patients require implantation of intracranial electrodes in order to determine the epileptogenic zone. A test known as SISCOM (subtraction ictal-interictal SPECT co-registered with MRI) has been validated as a non-invasive means of indicating the epileptogenic zone. However, this test is not widely available in the US, and it is not known how often the additional information provided by SISCOM makes a difference to clinical decision-making.

In order to determine the contribution of SISCOM towards clinical decision-making in epilepsy surgery candidates, we will ask epileptologists at Mayo Clinic to consider case presentations given all clinical information except for SISCOM results, and then to reconsider those same cases in conjunction with SISCOM data. This will indicate the degree to which SISCOM influences decision making.

50 patients at Mayo Clinic (38 adults, 12 children) will be enrolled.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Patients evaluated at Mayo Clinic and being considered for epilepsy surgery.
Epilepsy
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A
Candidates for epilepsy surgery, undergoing pre-surgical evaluation at Mayo Clinic, and in whom SISCOM was ordered by the treating physician as part of that evaluation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
February 2007
February 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of localization-related epilepsy
  • Evaluated by clinical epileptologist at Mayo Clinic
  • SISCOM ordered by treating physician
  • Case presented at weekly Epilepsy Surgery Conference
  • Patient consent
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00587951
2170-05
Yes
Dr. K. Meng Tan, Mayo Foundation
Mayo Clinic
Not Provided
Principal Investigator: Meng Tan, MD Mayo Clinic
Mayo Clinic
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP