NCT00587951

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 8, 2008

Completed
Last Updated

January 8, 2008

Status Verified

November 1, 2007

Enrollment Period

1.2 years

First QC Date

December 22, 2007

Last Update Submit

January 7, 2008

Conditions

Epilepsy

Keywords

Clinical decision-makingIctal SPECTEpilepsy surgery

Outcome Measures

Primary Outcomes (1)

  • Category of management recommendation (proceed straight to surgical resection, intracranial electrode implantation, more imaging studies OR recommend medical rather than surgical management)

    Instantaneous

Study Arms (1)

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Meng Tan, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 22, 2007

First Posted

January 8, 2008

Study Start

December 1, 2005

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

January 8, 2008

Record last verified: 2007-11

Locations

US(1)