Trial Outcomes & Findings for Arterial Spin Labeling MRI Focal Abnormalities in Refractory Epilepsy (NCT NCT01772654)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

73 participants

Primary outcome timeframe

Approximately in the middle of the MRI procedure

Results posted on

2015-03-06

Participant Flow

Subjects were recruited at Mayo Clinic in Rochester, Minnesota.

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	2	15
Overall Study COMPLETED	2	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Arterial Spin Labeling MRI Focal Abnormalities in Refractory Epilepsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Left Temporal Lobe Epilepsy Subjects n=2 Participants 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.	Control Subjects n=15 Participants 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.	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	14 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	11 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	15 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Left Temporal Lobe Epilepsy Subjects n=2 Participants 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.	Control Subjects n=15 Participants 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.
Intensity of the MRI Signal in the Left Temporal Precentral Zone	1.06 ratio Standard Deviation 0.05	1.04 ratio Standard Deviation 0.09

Adverse Events

Left Temporal Lobe Epilepsy Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cheolsu Shin, M.D.

Mayo Clinic

Phone: 507-284-4961

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place