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Arterial Spin Labeling MRI Focal Abnormalities in Refractory Epilepsy

Arterial Spin Labeling MRI Focal Abnormalities in Refractory Epilepsy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01772654
Enrollment
73
Registered
2013-01-21
Start date
2013-01-31
Completion date
2013-11-30
Last updated
2015-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focal Epilepsy

Keywords

Epilepsy, Arterial Spin Labeled MRI, Brain lesions, Cerebral blood flow

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.

Interventions

DEVICEArterial Spin Labeled (ASL) MRI sequence

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.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Intensity of the MRI Signal in the Left Temporal Precentral ZoneApproximately in the middle of the MRI procedureSubjects 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.

Countries

United States

Participant flow

Recruitment details

Subjects were recruited at Mayo Clinic in Rochester, Minnesota.

Pre-assignment details

73 subjects signed informed consent, but 56 subjects were excluded from analysis, as they turned out to have generalized epilepsy or non-localizable focal epilepsy. Patients who turned out not to have epilepsy, but non-epileptic behavioral spells served as control subjects. Two subjects were definitely left temporal onset and therefore analyzed.

Participants by arm

ArmCount
Left Temporal Lobe Epilepsy Subjects
Arterial Spin Labeled (ASL) MRI sequence Arterial Spin Labeled (ASL) MRI sequence: 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.
2
Control Subjects
Arterial Spin Labeled (ASL) MRI sequence Arterial Spin Labeled (ASL) MRI sequence: 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.
15
Total17

Baseline characteristics

CharacteristicLeft Temporal Lobe Epilepsy SubjectsControl SubjectsTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants1 Participants1 Participants
Age, Categorical
Between 18 and 65 years
2 Participants14 Participants16 Participants
Region of Enrollment
United States
2 participants15 participants17 participants
Sex: Female, Male
Female
2 Participants11 Participants13 Participants
Sex: Female, Male
Male
0 Participants4 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 20 / 15
serious
Total, serious adverse events
0 / 20 / 15

Outcome results

Primary

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.

Time frame: Approximately in the middle of the MRI procedure

ArmMeasureValue (MEAN)Dispersion
Left Temporal Lobe Epilepsy SubjectsIntensity of the MRI Signal in the Left Temporal Precentral Zone1.06 ratioStandard Deviation 0.05
Control SubjectsIntensity of the MRI Signal in the Left Temporal Precentral Zone1.04 ratioStandard Deviation 0.09

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026