Developing a Discrimination Model to Diagnose ALS

University of Michigan

Status: Completed

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Diagnostic Test: MRI(magnetic resonance imaging)

Study type: Interventional

Funder types: Other

Identifiers

NCT01995903

HUM00061126

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Amyotrophic lateral sclerosis

Experimental group

Description:

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.

Treatment:

Diagnostic Test: MRI(magnetic resonance imaging)

Healthy controls (MRI)

Active Comparator group

Description:

These subjects will undergo MRI (magnetic resonance imaging) scans of the brain to compare against diseased subjects.

Treatment:

Diagnostic Test: MRI(magnetic resonance imaging)