Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Arterial Spin Labeling MRI Focal Abnormalities in Refractory Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01772654
Recruitment Status : Completed
First Posted : January 21, 2013
Results First Posted : March 6, 2015
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Cheolsu Shin, Mayo Clinic

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Focal Epilepsy
Intervention Device: Arterial Spin Labeled (ASL) MRI sequence
Enrollment 73
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.
Arm/Group Title Left Temporal Lobe Epilepsy Subjects Control Subjects
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 2 15
Completed 2 15
Not Completed 0 0
Arm/Group Title Left Temporal Lobe Epilepsy Subjects Control Subjects Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 2 15 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 15 participants 17 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
14
  93.3%
16
  94.1%
>=65 years
0
   0.0%
1
   6.7%
1
   5.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 15 participants 17 participants
Female
2
 100.0%
11
  73.3%
13
  76.5%
Male
0
   0.0%
4
  26.7%
4
  23.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 15 participants 17 participants
2 15 17
1.Primary Outcome
Title Intensity of the MRI Signal in the Left Temporal Precentral Zone
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Left Temporal Lobe Epilepsy Subjects Control Subjects
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 2 15
Mean (Standard Deviation)
Unit of Measure: ratio
1.06  (0.05) 1.04  (0.09)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Left Temporal Lobe Epilepsy Subjects Control Subjects
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Left Temporal Lobe Epilepsy Subjects Control Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Left Temporal Lobe Epilepsy Subjects Control Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Left Temporal Lobe Epilepsy Subjects Control Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/15 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Cheolsu Shin, M.D.
Organization: Mayo Clinic
Phone: 507-284-4961
EMail: shin@mayo.edu
Responsible Party: Cheolsu Shin, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01772654     History of Changes
Other Study ID Numbers: 12-006882
First Submitted: January 17, 2013
First Posted: January 21, 2013
Results First Submitted: February 17, 2015
Results First Posted: March 6, 2015
Last Update Posted: March 6, 2015