Developing a Discrimination Model to Diagnose 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: NCT01995903 |
Recruitment Status :
Completed
First Posted : November 27, 2013
Last Update Posted : June 4, 2018
|
Sponsor:
University of Michigan
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 |
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 |
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 |
|
||||
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 |
50 | ||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
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 |
|
||||
IPD Sharing Statement ICMJE |
|
||||
Responsible Party | University of Michigan | ||||
Study Sponsor ICMJE | University of Michigan | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
|
||||
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 |