Developing a Discrimination Model to Diagnose ALS

• 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: November 4, 2013
• First Posted Date: November 27, 2013
• Last Update Posted Date: June 4, 2018
• Actual Study Start Date: April 2012
• Actual Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Developing a Discrimination Model to Diagnose ALS
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Amyotrophic Lateral Sclerosis

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 8, 2016): 50
• Original Estimated Enrollment (submitted: November 26, 2013): 90
• Actual Study Completion Date: October 2015
• Actual Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01995903
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: University of Michigan
• Study Sponsor: University of Michigan
• Collaborators: Not Provided

Investigators

• Principal Investigator: Bradley Foerster, M.D.; University of Michigan Hospital

• PRS Account: University of Michigan
• Verification Date: May 2018