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
  Purpose

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
Epilepsy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Influence of SISCOM on Intracranial Electrode Implantation in Epilepsy Surgical Candidates

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: December 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients evaluated at Mayo Clinic and being considered for epilepsy surgery.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587951

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

Additional Information:
No publications provided

Responsible Party: Dr. K. Meng Tan, Mayo Foundation
ClinicalTrials.gov Identifier: NCT00587951     History of Changes
Other Study ID Numbers: 2170-05
Study First Received: December 22, 2007
Last Updated: January 7, 2008
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 22, 2014