Clinical trial NCT00809224: Cortex Changes in Real/Imagined Movements in Amyotrophic Lateral Sclerosis (ALS)
Official title: Tracking Brain Changes During Real and Imagined Movements in People With ALS (Lou Gehrig's Disease) and Healthy Volunteers.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ALS
Amyotrophic Lateral Sclerosis
Keywords: ALS
amyotrophic lateral sclerosis
brain-computer interface
functional magnetic resonance imaging
radiology
fMRI
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2008-12-17
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All are able to participate.

Brief summary: 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.

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 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

Primary outcomes:
measure: cortical activation patterns
timeFrame: Yearly
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan, Functional MRI Laboratory
state: Michigan
Study officials:
affiliation: Research Assistant Professor, University of Michigan Department of Radiology
name: Robert Welsh, PhD
role: PRINCIPAL_INVESTIGATOR
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