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Developing a Discrimination Model to Diagnose ALS

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ClinicalTrials.gov Identifier: NCT01995903
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
University of Michigan

Tracking Information
First Submitted Date  ICMJE November 4, 2013
First Posted Date  ICMJE November 27, 2013
Last Update Posted Date June 4, 2018
Actual Study Start Date  ICMJE April 2012
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2017)
Developing a Discrimination Model to Diagnose ALS [ Time Frame: 5 years ]
We will measure brain fractional anisotropy (unitless) using diffusion tensor imaging of ALS patients and compare these to corresponding measures in healthy control subjects as well as patients with lower motor neuron signs only.
Original Primary Outcome Measures  ICMJE
 (submitted: November 26, 2013)
Developing a Discrimination Model to Diagnose ALS [ Time Frame: 5 years ]
We will measure brain fractional anisotropy (unitless) using diffusion tensor imaging of amyotrophic lateral sclerosis patients and compare these to corresponding measures in healthy control subjects as well as patients with lower motor neuron signs only.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Developing a Discrimination Model to Diagnose ALS
Official Title  ICMJE Developing a Discrimination Model to Diagnose ALS Using Advanced MRI Techniques
Brief Summary To combine several brain imaging techniques to develop a new diagnostic test to help with earlier diagnosis of amyotrophic lateral sclerosis.
Detailed Description Early diagnosis and lack of understanding of the pathophysiology of ALS remain a significant obstacle to making a timely intervention to help patients suffering from this fatal disease. We envision a future in which neuroimaging techniques will be a critical tool in the diagnostic work-up of ALS. Advanced neuroimaging techniques offer great potential in identifying central nervous system metabolite and cellular alterations in ALS. We propose an innovative approach to combine complementary advanced MRI techniques to interrogate brain chemistry (MRS), brain microstructure (DTI) and brain function (fcMRI) and develop a clinically relevant discriminatory disease model.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE Diagnostic Test: MRI(magnetic resonance imaging)
Subjects with amyotrophic lateral sclerosis and lower neuron motor skills and healthy subjects will undergo an MRI(magnetic resonance imaging)scans of the brain to assess neurologic condition. The brain scans will take approximately 60 minutes to complete.
Study Arms  ICMJE
  • Experimental: Amyotrophic lateral sclerosis
    Clinical examination for ALS(amyotrophic lateral sclerosis) and subjects with lower motor neuron signs will be completed. These subjects will undergo MRI (magnetic resonance imaging) scans of the brain to assess neurological conditions.
    Intervention: Diagnostic Test: MRI(magnetic resonance imaging)
  • Active Comparator: Healthy controls (MRI)
    These subjects will undergo MRI (magnetic resonance imaging) scans of the brain to compare against diseased subjects.
    Intervention: Diagnostic Test: MRI(magnetic resonance imaging)
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 Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2016)
50
Original Estimated Enrollment  ICMJE
 (submitted: November 26, 2013)
90
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 18 years of age or older
  2. subjects with ALS (amyotrophic lateral sclerosis)
  3. healthy subjects -

Exclusion Criteria:

  1. Active substance abuse
  2. Has co-morbid psychiatric disease
  3. Has opportunistic CNS (central nervous system) infection
  4. Has a history of head injury
  5. Has a contraindication for MRI (e.g. cardiac pacemaker, ferromagnetic or metallic implants)
  6. Pregnant
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 NCT01995903
Other Study ID Numbers  ICMJE HUM00061126
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device 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