Cortex Changes in Real/Imagined Movements in Amyotrophic Lateral Sclerosis (ALS)
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|ClinicalTrials.gov Identifier: NCT00809224|
Recruitment Status : Completed
First Posted : December 17, 2008
Last Update Posted : May 16, 2016
|Condition or disease|
|ALS Amyotrophic Lateral Sclerosis|
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.
|Study Type :||Observational|
|Actual Enrollment :||92 participants|
|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.|
|Study Start Date :||May 2008|
|Primary Completion Date :||May 2012|
|Study Completion Date :||May 2012|
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 ]
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
|United States, Michigan|
|University of Michigan, Functional MRI Laboratory|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Robert Welsh, PhD||Research Assistant Professor, University of Michigan Department of Radiology|