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

Not Applicable

Terminated

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Other: MRI; Other: Clinical Exam

• Registration Number: NCT02000713
• Lead Sponsor: University of Michigan

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-08
• Study First Submitted QC: 2013-11-26
• Study First Posted: 2013-12-04
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-31
• Last Update Posted: 2018-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Adults age 18 to 80 years of age.

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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) -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amyotrophic Lateral Sclerosis	MRI	All subjects will be interviewed and administered a brief questionnaire to determine current disease severity. A brief neurological examination will be given to determine reflexes. Subjects will also have magnetic resonance imaging(MRI)scans of the cervical spine (neck). Women of child-bearing potential will need to have a urine pregnancy test immediately prior to the MRI scan. Mri scan will take approximately 60 minutes to complete. The clinical examinations will take approximately 30 minutes to complete. Subject participation in this study will be complete following the MRI and clinical examinations.
Amyotrophic Lateral Sclerosis	Clinical Exam	All subjects will be interviewed and administered a brief questionnaire to determine current disease severity. A brief neurological examination will be given to determine reflexes. Subjects will also have magnetic resonance imaging(MRI)scans of the cervical spine (neck). Women of child-bearing potential will need to have a urine pregnancy test immediately prior to the MRI scan. Mri scan will take approximately 60 minutes to complete. The clinical examinations will take approximately 30 minutes to complete. Subject participation in this study will be complete following the MRI and clinical examinations.
Healthy controls (MRI)	MRI	Subjects will also have magnetic resonance imaging (MRI) scans of the cervical spine(neck). Women of child-bearing potential will need to have a urine pregnancy test immediately prior to the MRI scan. Mri scan will take approximately 60 minutes to complete. Subject participation in this study will be complete following the MRI.

Primary Outcome Measures

Name	Time	Method
Study levels of N-acetylaspartate (NAA)in the cervical spinal cord.	60 minutes or as needed (rarely more than 2 hours)	1. Study investigators will measure the differences in the spinal cord metabolite, N-acetylaspartate in ALS subjects compared to healthy controls using magnetic spectroscopy.

Secondary Outcome Measures

Name	Time	Method
Fractional anisotropy in the cervical spinal cord	3 years	Study fractional anisotropy levels (unitless) using diffusion tensor imaging in ALS patients compared to healthy controls in the cervical spinal cord.

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States