Back to resultsMagnetic Resonance Imaging (MRI) in Amyotrophic Lateral Sclerosis (ALS)
Primary Purpose
Amyotrophic Lateral Sclerosis (ALS)
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
7 Tesla MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Amyotrophic Lateral Sclerosis (ALS)
Eligibility Criteria
Inclusion Criteria:
- Males and Females who are 18 - 80 years old.
- The participants will meet the standard diagnostic criteria for possible or probable ALS (based on El Escorial criteria). They will have been diagnosed by a Johns Hopkins Neurologist.
- Healthy controls will be recruited by their interest in assisting the ALS population.
Exclusion Criteria:
- Forced vital capacity less than 60 % of predicted value.
- Documented orthopnea on ALSFRS-R or otherwise unable to lie flat in an MRI scanner for the duration of the study.
- Presence of pacemakers, aneurysm clips, shrapnel or otherwise disallowed implanted metallic devices for obtaining an MRI scan.
- Pregnant or lactating females
- Glomerular filtration rate (GFR) less than 60
- History of: encephalitis, extensive white matter disease, intracranial hemorrhage, cerebral palsy, allergy to dye and/or IV drug abuse.
Sites / Locations
- Johns Hopkins University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
7 Tesla MRI
Arm Description
7T MRI will be done on ALS patients at baseline and at 6 month intervals.
Outcomes
Primary Outcome Measures
MRI Changes in ALS Patients Vs Healthy Controls
Voxel Based Morphometry will be utilized to look for any changes in the MRI results comparing ALS subjects to healthy volunteers.
Secondary Outcome Measures
MRI Changes in ALS Patients
Voxel Based Morphometry will be utilized to look for any changes in the MRI results comparing ALS subjects comparing ALS subjects of differing clinical severity
Full Information
NCT ID
NCT01945853
First Posted
September 16, 2013
Last Updated
August 31, 2015
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT01945853
Brief Title
Magnetic Resonance Imaging (MRI) in Amyotrophic Lateral Sclerosis (ALS)
Official Title
Imaging Myelin Injury in Amyotrophic Lateral Sclerosis (ALS)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Study Start Date
July 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a pilot study to identify the degree of grey and white matter involvement in patients with Amyotrophic Lateral Sclerosis (ALS) utilizing non-invasive techniques. The imaging to be utilized will be the 7 Tesla (7T) magnetic resonance imaging (MRI) of the brain. These results will be correlated to the ALS Functional Rating Scale - Revised (ALSFRS-R) score to assess if any changes in MRI can be predictive in the disability of the ALS patients at baseline and at 6 month intervals. The participants will be asked to return every 6 months for a neurological examination, ALSFRS-R assessment, measurement of the vital capacity and MRI as outlined above to monitor progression of the disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis (ALS)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
7 Tesla MRI
Arm Type
Experimental
Arm Description
7T MRI will be done on ALS patients at baseline and at 6 month intervals.
Intervention Type
Device
Intervention Name(s)
7 Tesla MRI
Primary Outcome Measure Information:
Title
MRI Changes in ALS Patients Vs Healthy Controls
Description
Voxel Based Morphometry will be utilized to look for any changes in the MRI results comparing ALS subjects to healthy volunteers.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
MRI Changes in ALS Patients
Description
Voxel Based Morphometry will be utilized to look for any changes in the MRI results comparing ALS subjects comparing ALS subjects of differing clinical severity
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males and Females who are 18 - 80 years old.
The participants will meet the standard diagnostic criteria for possible or probable ALS (based on El Escorial criteria). They will have been diagnosed by a Johns Hopkins Neurologist.
Healthy controls will be recruited by their interest in assisting the ALS population.
Exclusion Criteria:
Forced vital capacity less than 60 % of predicted value.
Documented orthopnea on ALSFRS-R or otherwise unable to lie flat in an MRI scanner for the duration of the study.
Presence of pacemakers, aneurysm clips, shrapnel or otherwise disallowed implanted metallic devices for obtaining an MRI scan.
Pregnant or lactating females
Glomerular filtration rate (GFR) less than 60
History of: encephalitis, extensive white matter disease, intracranial hemorrhage, cerebral palsy, allergy to dye and/or IV drug abuse.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey D Rothstein, MD, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Magnetic Resonance Imaging (MRI) in Amyotrophic Lateral Sclerosis (ALS)
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