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Arterial Spin Labeling MRI Focal Abnormalities in Refractory Epilepsy

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Cheolsu Shin, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01772654
First received: January 17, 2013
Last updated: January 24, 2013
Last verified: January 2013
History of Changes
  Purpose

ASL sequences have been shown to localize certain epileptogenic abnormalities such as tubers in tuberous sclerosis. A previous study demonstrated ASL changes inter- and post-ictally in one patient without other MRI changes. This is a promising technique that has not been fully evaluated as of yet. Of note, all studies done in this area in regards to epilepsy have been retrospective, small studies. The investigators plan to perform a study that is prospective, with a comparatively large sample of patients.

The study hypothesis is that in patients with refractory epilepsy, Arterial Spin Labeling (ASL) MRI will show areas of abnormality in the brain to the same degree as SPECT and PET studies.


Condition Intervention
Focal Epilepsy
 Device: Arterial spin labeled (ASL) MRI sequence

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Arterial Spin Labeling MRI Focal Abnormalities in Refractory Epilepsy

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Imaging abnormalities on ASL MRI that correlate with PET and SPECT. [ Time Frame: 1-2 years ] [ Designated as safety issue: No ]
    correlation of ASL MRI abnormalities to PET and SPECT study abnormalities within the same patient.


Secondary Outcome Measures:
  • quantitative cerebral blood perfusion [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Determine quantitative cerebral blood perfusion changes in lesions detected by ASL MRI


Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arterial spin labeled (ASL) MRI sequence
Patients will have a standard epilepsy protocol (Mayo Clinic) MRI with additional ASL sequence performed during that MRI (Arterial spin labeled (ASL) MRI sequence).
 Device: Arterial spin labeled (ASL) MRI sequence

The arterial spin labeled MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.

This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence.

Detailed Description:

Currently, in presurgical evaluation of epilepsy patients, PET and SPECT studies are utilized to evaluate metabolic and perfusion abnormalities respectively to localize seizure onset. This is especially true in "MRI negative" patients, whose lesion is not visible on standard MRI techniques. PET and SPECT studies have numerous disadvantages, including radiation exposure, injection of contrast or isotopes, cost, and are often difficult to access for many patients.

Arterial spin labeling (ASL) MRI sequences show perfusion related abnormalities without using contrast, in a relatively short amount of time, and can be done during a normal MRI for evaluation of epilepsy. This is of interest because if there is a good correlation, ASL MRI sequences could be used in addition, or in place of, these other studies that require injection of isotopes and radiation from CT scans.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Medically refractory partial epilepsy.
  • Over the age of 18 years.
  • Scheduled to have routine epilepsy-protocol MRI after initial evaluation in neurology clinic at Mayo Clinic, Rochester.
  • Anticipated to undergo EMU monitoring.

Exclusion Criteria:

  • Patients with a generalized epilepsy.
  • Under the age of 18 years.
  • Unable to undergo MRI imaging of the brain.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01772654

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

Publications:

Responsible Party: Cheolsu Shin, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01772654     History of Changes
Other Study ID Numbers: 12-006882
Study First Received: January 17, 2013
Last Updated: January 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Epilepsy
Arterial Spin Labeled MRI
Brain lesions
Cerebral blood flow

Additional relevant MeSH terms:
Congenital Abnormalities
Epilepsy
Epilepsies, Partial
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013