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Trial record 15 of 488 for:    ALS (Amyotrophic Lateral Sclerosis)

Magnetic Resonance Imaging (MRI) in Amyotrophic Lateral Sclerosis (ALS)

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: NCT01945853
Recruitment Status : Withdrawn
First Posted : September 19, 2013
Last Update Posted : September 1, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Jeffrey Rothstein, Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis (ALS) Device: 7 Tesla MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Imaging Myelin Injury in Amyotrophic Lateral Sclerosis (ALS)
Study Start Date : July 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015


Arm Intervention/treatment
Experimental: 7 Tesla MRI
7T MRI will be done on ALS patients at baseline and at 6 month intervals.
Device: 7 Tesla MRI



Primary Outcome Measures :
  1. MRI Changes in ALS Patients Vs Healthy Controls [ Time Frame: 2 years ]
    Voxel Based Morphometry will be utilized to look for any changes in the MRI results comparing ALS subjects to healthy volunteers.


Secondary Outcome Measures :
  1. MRI Changes in ALS Patients [ Time Frame: 2 years ]
    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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01945853


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Jeffrey D Rothstein, MD, PhD Johns Hopkins University

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Responsible Party: Dr. Jeffrey Rothstein, Professor of Neurology, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01945853     History of Changes
Other Study ID Numbers: NA_00080565
First Posted: September 19, 2013    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
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Sclerosis
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases