Trial record 6 of 260 for:    Amyotrophic Lateral Sclerosis (ALS)

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Bradley Foerster M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT02000713
First received: November 8, 2013
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention
Amyotrophic Lateral Sclerosis
Procedure: Amyotrophic Lateral Sclerosis

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 University of Michigan:

Primary Outcome Measures:
  • Study levels of N-acetylaspartate (NAA)in the cervical spinal cord. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 2019
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.
Procedure: Amyotrophic Lateral Sclerosis
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02000713

Contacts
Contact: Bradley Foerster, M.D. 734-615-3586
Contact: Ladonna Austin, CCRC 734-936-8275 ladonna@umich.edu

Locations
United States, Michigan
University of Michigan Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Bradley Foerster, M.D.    734-615-3586      
Contact: Ladonna Austin, CCRC    734-936-8275    ladonna@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

No publications provided

Responsible Party: Bradley Foerster M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT02000713     History of Changes
Other Study ID Numbers: HUM00069508
Study First Received: November 8, 2013
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014