View Clinical Trial (Medical Research Study)
Cortex Changes in Real/Imagined Movements in Amyotrophic Lateral Sclerosis (ALS) - NCT00809224-48109(Clinical Trial 259639)
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| City: |
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Ann Arbor |
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State:
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MI |
| Zip Code: |
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48109 |
| Conditions: |
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ALS - Amyotrophic Lateral Sclerosis |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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University of Michigan, Functional MRI Laboratory Ann Arbor, MI 48109 United States
Primary Contact: Nick Rademacher Email: radenic@med.umich.edu Phone: 734-615-7086
Secondary Contact: Nick Rademacher, BS Email: radenic@med.umich.edu Phone: 734-615-7086 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
Modifications to
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