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

Not Applicable

Withdrawn

• Conditions: Amyotrophic Lateral Sclerosis (ALS)
• Interventions: Device: 7 Tesla MRI

• Registration Number: NCT01945853
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-09-16
• Study First Submitted QC: 2013-09-16
• Study First Posted: 2013-09-19
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
7 Tesla MRI	7 Tesla MRI	7T MRI will be done on ALS patients at baseline and at 6 month intervals.

Primary Outcome Measures

Name	Time	Method
MRI Changes in ALS Patients Vs Healthy Controls	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

Name	Time	Method
MRI Changes in ALS Patients	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

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States