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Completed

NCT Number: NCT01995903

Developing a Discrimination Model to Diagnose ALS

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

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Developing a Discrimination Model to Diagnose ALS Using Advanced MRI Techniques

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 27, 2013
Registry last updated
Jun 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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