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

• ClinicalTrials.gov Identifier: NCT02000713
• Recruitment Status: Terminated
• First Posted: December 4, 2013
• Last Update Posted: June 4, 2018
• Sponsor: University of Michigan
• Information provided by (Responsible Party): University of Michigan

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Amyotrophic Lateral Sclerosis	Other: MRI; Other: Clinical Exam	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Cervical Spinal Cord Metabolism and Microstructure in Amyotrophic Lateral Sclerosis(ALS)
• Study Start Date: October 2013
• Actual Primary Completion Date: August 2015
• Actual Study Completion Date: August 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Amyotrophic Lateral Sclerosis; 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.	Other: MRI; 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.; Other: Clinical Exam; Brief neurological exam will be performed.
Active Comparator: Healthy controls (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.	Other: MRI; 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.

Outcome Measures

Primary Outcome Measures :

1. Study levels of N-acetylaspartate (NAA)in the cervical spinal cord. [ Time Frame: 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 :

1. Fractional anisotropy in the cervical spinal cord [ Time Frame: 3 years ]
   Study fractional anisotropy levels (unitless) using diffusion tensor imaging in ALS patients compared to healthy controls in the cervical spinal cord.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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) -

Contacts and Locations

Locations

United States, Michigan

University of Michigan Hospital

Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan

Investigators

• Principal Investigator: Bradley Foerster, M.D.; University of Michigan Hospital

More Information

• Responsible Party: University of Michigan
• ClinicalTrials.gov Identifier: NCT02000713
• Other Study ID Numbers: HUM00069508
• First Posted: December 4, 2013
• Last Update Posted: June 4, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No

Additional relevant MeSH terms:

Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis; Pathologic Processes; Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases; Spinal Cord Diseases; Central Nervous System Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases