Developing a Discrimination Model to Diagnose ALS

NCT01995903 | Completed DMC

• 1 other identifier: HUM00061126
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Amyotrophic lateral sclerosis

EXPERIMENTAL

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.

Diagnostic Test: MRI(magnetic resonance imaging)

Healthy controls (MRI)

ACTIVE COMPARATOR

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

Diagnostic Test: MRI(magnetic resonance imaging)

Interventions

MRI(magnetic resonance imaging) 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.

Amyotrophic lateral sclerosis; Healthy controls (MRI)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• subjects with ALS (amyotrophic lateral sclerosis)
• healthy subjects -

You may not qualify if:

• Active substance abuse
• Has co-morbid psychiatric disease
• Has opportunistic CNS (central nervous system) infection
• Has a history of head injury
• Has a contraindication for MRI (e.g. cardiac pacemaker, ferromagnetic or metallic implants)
• Pregnant

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Bradley Foerster, M.D.

  University of Michigan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 27, 2013
• Study Start: April 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: June 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)