NCT01772654

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 21, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 6, 2015

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

10 months

First QC Date

January 17, 2013

Results QC Date

February 17, 2015

Last Update Submit

March 4, 2015

Conditions

Focal Epilepsy

Keywords

EpilepsyArterial Spin Labeled MRIBrain lesionsCerebral blood flow

Outcome Measures

Primary Outcomes (1)

  • 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.

    Approximately in the middle of the MRI procedure

Study Arms (2)

Left Temporal Lobe Epilepsy Subjects

EXPERIMENTAL

Arterial Spin Labeled (ASL) MRI sequence

Device: Arterial Spin Labeled (ASL) MRI sequence

Control Subjects

ACTIVE COMPARATOR

Arterial Spin Labeled (ASL) MRI sequence

Device: Arterial Spin Labeled (ASL) MRI sequence

Interventions

Arterial Spin Labeled (ASL) MRI sequenceDEVICE

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 SubjectsLeft Temporal Lobe Epilepsy Subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

    PMID: 19674791BACKGROUND

MeSH Terms

Conditions

Epilepsies, PartialEpilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Limitations and Caveats

Small sample size.

Results Point of Contact

Title
Cheolsu Shin, M.D.
Organization
Mayo Clinic
shin@mayo.edu
507-284-4961

Study Officials

  • Cheolsu Shin, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

January 17, 2013

First Posted

January 21, 2013

Study Start

January 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

March 6, 2015

Results First Posted

March 6, 2015

Record last verified: 2015-03

Locations

US(1)