Developing a Discrimination Model to Diagnose ALS

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Developing a Discrimination Model to Diagnose ALS Using Advanced MRI Techniques

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01995903
• Other study ID #: HUM00061126
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: October 2015

Study information

• Verified date: May 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

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.

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years