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

NCT ID: NCT00587951

Last Updated: 2008-01-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2007-02-28

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.

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.

Conditions

Epilepsy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Foundation

Principal Investigators

Meng Tan, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

2170-05

Identifier Type: -

Identifier Source: org_study_id