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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00809224
First received: December 15, 2008
Last updated: May 26, 2009
Last verified: December 2008
  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 University of Michigan:

Primary Outcome Measures:
  • cortical activation patterns [ Time Frame: Yearly ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2008
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00809224

Contacts
Contact: Nick Rademacher, BS 734-615-7086 radenic@med.umich.edu
Contact: Saugy Chakraborty, MS 734.615.4650 saugyc@med.umich.edu

Locations
United States, Michigan
University of Michigan, Functional MRI Laboratory Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Nick Rademacher    734-615-7086    radenic@med.umich.edu   
Principal Investigator: Robert Welsh, PhD         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Robert Welsh, PhD Research Assistant Professor, University of Michigan Department of Radiology
  More Information

Additional Information:
Publications:

Responsible Party: Dr. Robert Welsh, Research Assistant Professor, University of Michigan Department of Radiology, University of Michigan
ClinicalTrials.gov Identifier: NCT00809224     History of Changes
Other Study ID Numbers: R01NS052514, Hum00000219
Study First Received: December 15, 2008
Last Updated: May 26, 2009
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on April 16, 2014