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

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Johns Hopkins University

Status

Withdrawn

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Treatments

Device: 7 Tesla MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT01945853
NA_00080565

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

7 Tesla MRI
Experimental group
Description:
7T MRI will be done on ALS patients at baseline and at 6 month intervals.
Treatment:
Device: 7 Tesla MRI

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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