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

This study is currently recruiting participants.
Verified April 2017 by Bradley Foerster M.D., University of Michigan
Sponsor:
ClinicalTrials.gov Identifier:
NCT02000713
First Posted: December 4, 2013
Last Update Posted: April 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bradley Foerster M.D., University of Michigan
  Purpose
The investigators want to know if magnetic resonance imaging can accurately provide an early diagnosis of amyotrophic lateral sclerosis (ALS).

Condition Intervention
Amyotrophic Lateral Sclerosis Other: MRI Other: Clinical Exam

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Bradley Foerster M.D., University of Michigan:

Primary Outcome Measures:
  • 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:
  • 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.


Estimated Enrollment: 25
Study Start Date: October 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000713


Contacts
Contact: Bradley Foerster, M.D. 734-615-3586

Locations
United States, Michigan
University of Michigan Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Bradley Foerster, M.D.    734-615-3586      
Contact: Ian Crumb, BS    734-747-9545    ccrumb@umich.edu   
Principal Investigator: Bradley Foerster, M.D.         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Bradley Foerster, M.D. University of Michigan Hospital
  More Information

Responsible Party: Bradley Foerster M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT02000713     History of Changes
Other Study ID Numbers: HUM00069508
First Submitted: November 8, 2013
First Posted: December 4, 2013
Last Update Posted: April 24, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Sclerosis
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases