Developing a Discrimination Model to Diagnose ALS

NCT ID: NCT01995903

Last Updated: 2018-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2015-10-31

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.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MRI(magnetic resonance imaging)

Intervention Type: DIAGNOSTIC_TEST

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.

Healthy controls (MRI)

These subjects will undergo MRI (magnetic resonance imaging) scans of the brain to compare against diseased subjects.

Group Type: ACTIVE_COMPARATOR

MRI(magnetic resonance imaging)

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bradley Foerster, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Hospital

Locations

University of Michigan Hospital

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00061126

Identifier Type: -

Identifier Source: org_study_id