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

Imaging Myelin Injury in Amyotrophic Lateral Sclerosis (ALS)

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01945853

Enrollment

Registered

2013-09-19

Start date

2013-07-31

Completion date

2015-04-30

Last updated

2015-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis (ALS)

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.

Interventions

DEVICE7 Tesla MRI

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026