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Completed

NCT Number: NCT01772654

Arterial Spin Labeling MRI Focal Abnormalities in Refractory Epilepsy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Arterial Spin Labeled (ASL) MRI sequence

Device

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 outcomes

  1. Intensity of the MRI Signal in the Left Temporal Precentral Zone

    Time frame: Approximately in the middle of the MRI procedure

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 21, 2013
Registry last updated
Mar 6, 2015

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.

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