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Trial record 67 of 518 for:    ALS (Amyotrophic Lateral Sclerosis)

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02000713
Recruitment Status : Terminated (Principle Investigator was unable to fulfill responsibilities.)
First Posted : December 4, 2013
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
University of Michigan

Tracking Information
First Submitted Date  ICMJE November 8, 2013
First Posted Date  ICMJE December 4, 2013
Last Update Posted Date June 4, 2018
Study Start Date  ICMJE October 2013
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 26, 2013)
Study levels of N-acetylaspartate (NAA)in the cervical spinal cord. [ Time Frame: 3 years ]
1. Study investigators will measure the differences in the spinal cord metabolite, N-acetylaspartate in ALS subjects compared to healthy controls using magnetic spectroscopy.
Change History Complete list of historical versions of study NCT02000713 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cervical Spinal Cord Metabolism and Microstructure in Amyotrophic Lateral Sclerosis(ALS)
Official Title  ICMJE Cervical Spinal Cord Metabolism and Microstructure in Amyotrophic Lateral Sclerosis(ALS)
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: MRI
    • Other: Clinical Exam
  • 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.
    Intervention: Other: MRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 31, 2018)
20
Original Estimated Enrollment  ICMJE
 (submitted: November 26, 2013)
25
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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) -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02000713
Other Study ID Numbers  ICMJE HUM00069508
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bradley Foerster, M.D. University of Michigan Hospital
PRS Account University of Michigan
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP