An observational study in ALS and Amyotrophic Lateral Sclerosis, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-16.
Sponsored by University of Michigan · Observational
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.
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.
717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.
This study's enrollment of 92 is below the median of 109 across 217 observational studies indexed under Motor Neuron Disease.
Browse Motor Neuron Disease studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
All are able to participate.
Inclusion Criteria:
Participants with and without ALS must:
ALS group should have ALS.
The control group should not have ALS or any other neurological/psychiatric disorder, and must be over the age of 40.
cortical activation patterns
Time frame: Yearly
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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University of Michigan