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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00587951
Recruitment Status : Completed
First Posted : January 8, 2008
Last Update Posted : January 8, 2008
Information provided by:
Mayo Clinic

Brief Summary:

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.

Condition or disease

Detailed Description:

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.

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Influence of SISCOM on Intracranial Electrode Implantation in Epilepsy Surgical Candidates
Study Start Date : December 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients evaluated at Mayo Clinic and being considered for epilepsy surgery.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00587951

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Meng Tan, MD Mayo Clinic

Additional Information:
Responsible Party: Dr. K. Meng Tan, Mayo Foundation Identifier: NCT00587951     History of Changes
Other Study ID Numbers: 2170-05
First Posted: January 8, 2008    Key Record Dates
Last Update Posted: January 8, 2008
Last Verified: November 2007

Keywords provided by Mayo Clinic:
Clinical decision-making
Epilepsy surgery

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases