Back to resultsDeveloping a Discrimination Model to Diagnose ALS
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI(magnetic resonance imaging)
Sponsored by
About this trial
This is an interventional diagnostic trial for Amyotrophic Lateral Sclerosis
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- subjects with ALS (amyotrophic lateral sclerosis)
- healthy subjects -
Exclusion Criteria:
- Active substance abuse
- Has co-morbid psychiatric disease
- Has opportunistic CNS (central nervous system) infection
- Has a history of head injury
- Has a contraindication for MRI (e.g. cardiac pacemaker, ferromagnetic or metallic implants)
- Pregnant
Sites / Locations
- University of Michigan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Amyotrophic lateral sclerosis
Healthy controls (MRI)
Arm Description
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.
These subjects will undergo MRI (magnetic resonance imaging) scans of the brain to compare against diseased subjects.
Outcomes
Primary Outcome Measures
Developing a Discrimination Model to Diagnose ALS
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01995903
Brief Title
Developing a Discrimination Model to Diagnose ALS
Official Title
Developing a Discrimination Model to Diagnose ALS Using Advanced MRI Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 2012 (Actual)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amyotrophic lateral sclerosis
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy controls (MRI)
Arm Type
Active Comparator
Arm Description
These subjects will undergo MRI (magnetic resonance imaging) scans of the brain to compare against diseased subjects.
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI(magnetic resonance imaging)
Intervention Description
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 Measure Information:
Title
Developing a Discrimination Model to Diagnose ALS
Description
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.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
subjects with ALS (amyotrophic lateral sclerosis)
healthy subjects -
Exclusion Criteria:
Active substance abuse
Has co-morbid psychiatric disease
Has opportunistic CNS (central nervous system) infection
Has a history of head injury
Has a contraindication for MRI (e.g. cardiac pacemaker, ferromagnetic or metallic implants)
Pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley Foerster, M.D.
Organizational Affiliation
University of Michigan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Developing a Discrimination Model to Diagnose ALS
We'll reach out to this number within 24 hrs