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Cortex Changes in Real/Imagined Movements in Amyotrophic Lateral Sclerosis (ALS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00809224
First Posted: December 17, 2008
Last Update Posted: May 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Robert Welsh, University of Michigan
  Purpose
The purpose of this study is to track areas of the brain, via functional magnetic resonance imaging (fMRI), that retain structural and functional integrity throughout the lifespan of people with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease.

Condition
ALS Amyotrophic Lateral Sclerosis

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Tracking Brain Changes During Real and Imagined Movements in People With ALS (Lou Gehrig's Disease) and Healthy Volunteers.

Resource links provided by NLM:


Further study details as provided by Robert Welsh, University of Michigan:

Primary Outcome Measures:
  • cortical activation patterns [ Time Frame: Yearly ]

Enrollment: 92
Study Start Date: May 2008
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
ALS
ALS group should have ALS.
Control
The control group should not have ALS or any other neurological/psychiatric disorder, and must be over the age of 40.

Detailed Description:

A severe physical disability has a dramatic impact on a person's life, whether it is caused by a neuro-degenerative disease such as amyotrophic lateral sclerosis (ALS), a brainstem stroke, or a spinal cord injury. Someone with these conditions may be effectively "locked-in," retaining their cognitive ability, but unable to perform any movement except, possibly, the most basic eye movements.

Areas of the brain that retain structural and functional integrity throughout the lifespan of people with ALS may be suitable for a technology called brain-computer interfaces (BCI). One day, BCIs—which can be operated "just by thinking"—may allow people with neurological disorders, such as ALS, to communicate and regain some mobility with the assistance of electronic devices.

In this study we will use functional magnetic resonance imaging (fMRI) to track areas of the brain that retain structural and functional integrity throughout the lifespan of people with ALS.

The trial involves visits to the study facility every 2-6 months for up to 30 months or until visits are no longer possible. During each visit, participants will undergo a fMRI exam. During that time they will view visual images and be asked to perform 4 different motor tasks: 1) actual finger tapping, 2) actual fist clenching, 3) imaginary finger tapping, and 4) imaginary fist clenching. Each of the mini-experiments (tasks) lasts for about 6-7 minutes. While the participants are performing the tasks their brains will be repeatedly imaged using fMRI. We will then use the images to look for correlations to the tasks, which in turn will result in identifying the brain areas responsible for the activities. After the fMRI, participants will be asked to fill out questionnaires. Performing the tasks takes about 90 minutes and filling out the questionnaires takes about 30 minutes.

The facility is located on the North Campus of the University of Michigan-Ann Arbor. The study coordinators currently are enrolling participants with ALS and creating a database of healthy volunteers whom they will contact at a later date.

Information gained from this study will contribute to a better understanding of ALS disease progression, and could lead to significant quality-of-life improvements for persons with end-stage ALS.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All are able to participate.
Criteria

Inclusion Criteria:

Participants with and without ALS must:

  • be between 18 and 70 years of age
  • not be claustrophobic
  • not have metal particles in their eyes
  • not have metal implants (joints, inner ear, pacemaker, etc.) or foreign metal in their body
  • not have a history of neurological or psychiatric disorder
  • not have a history of alcohol or drug abuse
  • be able to lie on their back for 90 minutes
  • not be dependent on artificial ventilation
  • not be on PiPap, or must be capable of being off it for greater than 6 hours
  • healthy controls must be over the age of 40
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00809224


Locations
United States, Michigan
University of Michigan, Functional MRI Laboratory
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Robert Welsh, PhD Research Assistant Professor, University of Michigan Department of Radiology
  More Information

Additional Information:
Publications:

Responsible Party: Robert Welsh, Research Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00809224     History of Changes
Other Study ID Numbers: R01NS052514 ( U.S. NIH Grant/Contract )
Hum00000219
First Submitted: December 15, 2008
First Posted: December 17, 2008
Last Update Posted: May 16, 2016
Last Verified: May 2016

Keywords provided by Robert Welsh, University of Michigan:
ALS
amyotrophic lateral sclerosis
brain-computer interface
functional magnetic resonance imaging
radiology
fMRI

Additional relevant MeSH terms:
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases