Cervical Spinal Cord Metabolism and Microstructure in Amyotrophic Lateral Sclerosis(ALS)

N/ATerminatedNCT02000713

University of Michigan20 enrolled

Overview

The investigators want to know if magnetic resonance imaging can accurately provide an early diagnosis of amyotrophic lateral sclerosis (ALS).

Currently there is no definitive diagnostic test for amyotrophic lateral sclerosis (ALS). The investigators' goal is to determine if magnetic resonance imaging can provide an accurate diagnosis of ALS by looking at chemical concentrations in the spinal cord at the neck level which show up in MRI imaging and compare these chemical concentrations to corresponding measures in healthy control subjects.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Amyotrophic Lateral Sclerosis

Interventions

MRIOTHER

Subjects will have magnetic resonance imaging(MRI)scans of the cervical spine(neck). This involves lying on a table and sliding into a scanner consisting of a large magnet. This will take approximately one hour to complete. All subjects will be instructed to remove all jewelry and other metal-containing objects for the scan. During the MRI scan loud noises may be heard. Subjects may have a soft brace for the neck for positioning purposes.

Clinical ExamOTHER

Brief neurological exam will be performed.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1\. Adults age 18 to 80 years of age. Exclusion Criteria: 1. Do not have active substance abuse 2. Do not have co-morbid psychiatric disease 3. Do not have opportunistic central nervous system infection 4. Do not have cerebrovascular disease 5. Do not have a contraindication for magnetic resonance imaging(MRI)(e.g. cardiac pacemaker, ferromagnetic or metallic implants). 6. Are not pregnant 7. Have not had cervical spinal surgery(neck) -

Locations (1)

University of Michigan Hospital

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Study levels of N-acetylaspartate (NAA)in the cervical spinal cord.

1\. Study investigators will measure the differences in the spinal cord metabolite, N-acetylaspartate in ALS subjects compared to healthy controls using magnetic spectroscopy.

Time frame: 60 minutes or as needed (rarely more than 2 hours)

Secondary Outcomes

Fractional anisotropy in the cervical spinal cord

Study fractional anisotropy levels (unitless) using diffusion tensor imaging in ALS patients compared to healthy controls in the cervical spinal cord.

Time frame: 3 years

Data from ClinicalTrials.gov

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