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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

Brief Summary:
To combine several brain imaging techniques to develop a new diagnostic test to help with earlier diagnosis of amyotrophic lateral sclerosis.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Diagnostic Test: MRI(magnetic resonance imaging) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Developing a Discrimination Model to Diagnose ALS Using Advanced MRI Techniques
Actual Study Start Date : April 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015


Arm Intervention/treatment
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.
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.

Active Comparator: Healthy controls (MRI)
These subjects will undergo MRI (magnetic resonance imaging) scans of the brain to compare against diseased subjects.
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.




Primary Outcome Measures :
  1. 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.



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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. 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

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): NCT01995903


Locations
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United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Bradley Foerster, M.D. University of Michigan Hospital
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Responsible Party: University of Michigan
ClinicalTrials.gov Identifier: NCT01995903    
Other Study ID Numbers: HUM00061126
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases