Developing a Discrimination Model to Diagnose ALS

Developing a Discrimination Model to Diagnose ALS Using Advanced MRI Techniques

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01995903

Enrollment

Registered

2013-11-27

Start date

2012-04-30

Completion date

2015-10-31

Last updated

2018-06-04

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

Conditions

Amyotrophic Lateral Sclerosis

Brief summary

To combine several brain imaging techniques to develop a new diagnostic test to help with earlier diagnosis of amyotrophic lateral sclerosis.

Detailed description

Early diagnosis and lack of understanding of the pathophysiology of ALS remain a significant obstacle to making a timely intervention to help patients suffering from this fatal disease. We envision a future in which neuroimaging techniques will be a critical tool in the diagnostic work-up of ALS. Advanced neuroimaging techniques offer great potential in identifying central nervous system metabolite and cellular alterations in ALS. We propose an innovative approach to combine complementary advanced MRI techniques to interrogate brain chemistry (MRS), brain microstructure (DTI) and brain function (fcMRI) and develop a clinically relevant discriminatory disease model.

Interventions

DIAGNOSTIC_TESTMRI(magnetic resonance imaging)

Subjects with amyotrophic lateral sclerosis and lower neuron motor skills and healthy subjects will undergo an MRI(magnetic resonance imaging)scans of the brain to assess neurologic condition. The brain scans will take approximately 60 minutes to complete.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

1. 18 years of age or older 2. subjects with ALS (amyotrophic lateral sclerosis) 3. healthy subjects -

Exclusion criteria

1. Active substance abuse 2. Has co-morbid psychiatric disease 3. Has opportunistic CNS (central nervous system) infection 4. Has a history of head injury 5. Has a contraindication for MRI (e.g. cardiac pacemaker, ferromagnetic or metallic implants) 6. Pregnant

Design outcomes

Primary

Measure	Time frame	Description
Developing a Discrimination Model to Diagnose ALS	5 years	We will measure brain fractional anisotropy (unitless) using diffusion tensor imaging of ALS patients and compare these to corresponding measures in healthy control subjects as well as patients with lower motor neuron signs only.

Countries

United States

Outcome results

None listed

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