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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2007
First posted: Jan 8, 2008
Registry last updated: Jan 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed