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

NCT01945853 | Withdrawn

• 1 other identifier: NA_00080565
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

• MRI Changes in ALS Patients

  2 years

Study Arms (1)

7 Tesla MRI

EXPERIMENTAL

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

Device: 7 Tesla MRI

Interventions

7 Tesla MRI DEVICE

7 Tesla MRI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jeffrey D Rothstein, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: September 16, 2013
• First Posted: September 19, 2013
• Study Start: July 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: September 1, 2015

Record last verified: 2015-08

Locations

US (1)