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Arterial Spin Labeling MRI Focal Abnormalities in Refractory Epilepsy

Primary Purpose

Focal Epilepsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arterial Spin Labeled (ASL) MRI sequence
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Focal Epilepsy focused on measuring Epilepsy, Arterial Spin Labeled MRI, Brain lesions, Cerebral blood flow

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 epilepsy monitoring unit (EMU) monitoring.

Exclusion Criteria:

  • Patients with a generalized epilepsy.
  • Under the age of 18 years.
  • Unable to undergo MRI imaging of the brain.

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Left Temporal Lobe Epilepsy Subjects

Control Subjects

Arm Description

Arterial Spin Labeled (ASL) MRI sequence

Arterial Spin Labeled (ASL) MRI sequence

Outcomes

Primary Outcome Measures

Intensity of the MRI Signal in the Left Temporal Precentral Zone
Subjects who were already scheduled to have a Magnetic Resonance Imaging (MRI) procedure as part of an evaluation for epilepsy had an additional sequence added during the MRI. The additional MRI sequence was called Arterial Spin Labeling (ASL), and consisted of 4 minutes additional time in the MRI scanner. The ASL sequence did not use any contrast or radiation. The ASL sequence is a blood flow measure, and compared the intensity of the MRI signal in patients with left temporal lobe epilepsy to the intensity of the MRI signal in patients with normal brains. Intensity of MRI signal is measured on the MRI image slices in different anatomic regions as an optical density (dark to bright). It is then referenced to a region of the brain that is considered stable standard as a ratio.

Secondary Outcome Measures

Full Information

First Posted
January 17, 2013
Last Updated
March 4, 2015
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01772654
Brief Title
Arterial Spin Labeling MRI Focal Abnormalities in Refractory Epilepsy
Official Title
Arterial Spin Labeling MRI Focal Abnormalities in Refractory Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate a type of Magnetic Resonance Imaging (MRI) sequence called arterial spin labeling (ASL). The investigators hope that ASL can better localize areas of the brain (lesions) that cause epilepsy. This type of MRI does not require contrast, does not use any radiation, and adds on 4 minutes to the routine MRI that is done for patients with epilepsy. 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 single-photon emission computerized tomography (SPECT) and positron emission tomography (PET) studies.
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. 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. Study Design: Consultants in the epilepsy clinic will identify potential subjects on the patients' initial evaluation. Just after the consultation is finished, in the epilepsy clinic, the study will be described to the patient along with risks and benefits, and informed consent will be obtained by one of the researchers or research personnel in the clinic. If the patient agrees with the study, the MRI department will be notified of the patient's participation. At that time, the patient's already scheduled MRI will have the addition of ASL sequences. This will add approximately 4 minutes to the MRI. The patient will then have other imaging investigations as deemed necessary by the treating consultant. This may include PET and SPECT. If the patient is admitted to the EMU, ictal and interictal SPECT are likely to be done. After the patient has had the full evaluation, we will compare the ASL MRI sequences to the basic MRI, and PET and SPECT if performed. We will also use software already developed to determine the quantitative blood flow to the abnormalities found on the ASL sequences.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Epilepsy
Keywords
Epilepsy, Arterial Spin Labeled MRI, Brain lesions, Cerebral blood flow

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Left Temporal Lobe Epilepsy Subjects
Arm Type
Experimental
Arm Description
Arterial Spin Labeled (ASL) MRI sequence
Arm Title
Control Subjects
Arm Type
Active Comparator
Arm Description
Arterial Spin Labeled (ASL) MRI sequence
Intervention Type
Device
Intervention Name(s)
Arterial Spin Labeled (ASL) MRI sequence
Intervention Description
The Arterial Spin Labeled (ASL) 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.
Primary Outcome Measure Information:
Title
Intensity of the MRI Signal in the Left Temporal Precentral Zone
Description
Subjects who were already scheduled to have a Magnetic Resonance Imaging (MRI) procedure as part of an evaluation for epilepsy had an additional sequence added during the MRI. The additional MRI sequence was called Arterial Spin Labeling (ASL), and consisted of 4 minutes additional time in the MRI scanner. The ASL sequence did not use any contrast or radiation. The ASL sequence is a blood flow measure, and compared the intensity of the MRI signal in patients with left temporal lobe epilepsy to the intensity of the MRI signal in patients with normal brains. Intensity of MRI signal is measured on the MRI image slices in different anatomic regions as an optical density (dark to bright). It is then referenced to a region of the brain that is considered stable standard as a ratio.
Time Frame
Approximately in the middle of the MRI procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 epilepsy monitoring unit (EMU) monitoring. Exclusion Criteria: Patients with a generalized epilepsy. Under the age of 18 years. Unable to undergo MRI imaging of the brain.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheolsu Shin, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19674791
Citation
Pendse N, Wissmeyer M, Altrichter S, Vargas M, Delavelle J, Viallon M, Federspiel A, Seeck M, Schaller K, Lovblad KO. Interictal arterial spin-labeling MRI perfusion in intractable epilepsy. J Neuroradiol. 2010 Mar;37(1):60-3. doi: 10.1016/j.neurad.2009.05.006. Epub 2009 Aug 11.
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Arterial Spin Labeling MRI Focal Abnormalities in Refractory Epilepsy

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