Developing a Discrimination Model to Diagnose ALS

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

Detailed Description
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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.

Official Title
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Developing a Discrimination Model to Diagnose ALS Using Advanced MRI Techniques

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Diagnostic Test: MRI(magnetic resonance imaging)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older subjects with ALS (amyotrophic lateral sclerosis) healthy subjects - Exclusion Criteria: Active substance abuse Has co-morbid psychiatric disease Has opportunistic CNS (central nervous system) infection Has a history of head injury Has a contraindication for MRI (e.g. cardiac pacemaker, ferromagnetic or metallic implants) Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amyotrophic lateral sclerosis<br>Clinical examination for ALS(amyotrophic lateral sclerosis) and subjects with lower motor neuron signs will be completed. These subjects will undergo MRI (magnetic resonance imaging) scans of the brain to assess neurological conditions. | Diagnostic Test: MRI(magnetic resonance imaging)<br>* 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.<br>|
| Active Comparator: Healthy controls (MRI)<br>These subjects will undergo MRI (magnetic resonance imaging) scans of the brain to compare against diseased subjects. | Diagnostic Test: MRI(magnetic resonance imaging)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Developing a Discrimination Model to Diagnose ALS | 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. | 5 years |