Developing a Discrimination Model to Diagnose ALS

Not Applicable

Completed

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Diagnostic Test: MRI(magnetic resonance imaging)

• Registration Number: NCT01995903
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-04
• Study First Submitted: 2013-11-04
• Study First Submitted QC: 2013-11-26
• Study First Posted: 2013-11-27
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-31
• Last Update Posted: 2018-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy controls (MRI)	MRI(magnetic resonance imaging)	These subjects will undergo MRI (magnetic resonance imaging) scans of the brain to compare against diseased subjects.
Amyotrophic lateral sclerosis	MRI(magnetic resonance imaging)	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.

Primary Outcome Measures

Name	Time	Method
Developing a Discrimination Model to Diagnose ALS	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.

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States