Cortex Changes in Real/Imagined Movements in Amyotrophic Lateral Sclerosis (ALS)
NCT ID: NCT00809224
Last Updated: 2016-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
92 participants
OBSERVATIONAL
2008-05-31
2012-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
Study Groups
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ALS
ALS group should have ALS.
No interventions assigned to this group
Control
The control group should not have ALS or any other neurological/psychiatric disorder, and must be over the age of 40.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Michigan
OTHER
Responsible Party
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Robert Welsh
Research Associate Professor
Principal Investigators
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Robert Welsh, PhD
Role: PRINCIPAL_INVESTIGATOR
Research Assistant Professor, University of Michigan Department of Radiology
Locations
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University of Michigan, Functional MRI Laboratory
Ann Arbor, Michigan, United States
Countries
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References
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Abrahams S, Goldstein LH, Simmons A, Brammer M, Williams SC, Giampietro V, Leigh PN. Word retrieval in amyotrophic lateral sclerosis: a functional magnetic resonance imaging study. Brain. 2004 Jul;127(Pt 7):1507-17. doi: 10.1093/brain/awh170. Epub 2004 May 26.
Biswal BB, Van Kylen J, Hyde JS. Simultaneous assessment of flow and BOLD signals in resting-state functional connectivity maps. NMR Biomed. 1997 Jun-Aug;10(4-5):165-70. doi: 10.1002/(sici)1099-1492(199706/08)10:4/53.0.co;2-7.
Brooks BR, Bushara K, Khan A, Hershberger J, Wheat JO, Belden D, Henningsen H. Functional magnetic resonance imaging (fMRI) clinical studies in ALS--paradigms, problems and promises. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000 Jun;1 Suppl 2:S23-32. doi: 10.1080/14660820052415790.
Havel P, Braun B, Rau S, Tonn JC, Fesl G, Bruckmann H, Ilmberger J. Reproducibility of activation in four motor paradigms. An fMRI study. J Neurol. 2006 Apr;253(4):471-6. doi: 10.1007/s00415-005-0028-4. Epub 2005 Nov 14.
Jacob S, Finsterbusch J, Weishaupt JH, Khorram-Sefat D, Frahm J, Ehrenreich H. Diffusion tensor imaging for long-term follow-up of corticospinal tract degeneration in amyotrophic lateral sclerosis. Neuroradiology. 2003 Sep;45(9):598-600. doi: 10.1007/s00234-003-1014-0. Epub 2003 Aug 7.
Konrad C, Henningsen H, Bremer J, Mock B, Deppe M, Buchinger C, Turski P, Knecht S, Brooks B. Pattern of cortical reorganization in amyotrophic lateral sclerosis: a functional magnetic resonance imaging study. Exp Brain Res. 2002 Mar;143(1):51-6. doi: 10.1007/s00221-001-0981-9. Epub 2002 Jan 24.
Konrad C, Jansen A, Henningsen H, Sommer J, Turski PA, Brooks BR, Knecht S. Subcortical reorganization in amyotrophic lateral sclerosis. Exp Brain Res. 2006 Jul;172(3):361-9. doi: 10.1007/s00221-006-0352-7. Epub 2006 Mar 25.
Sach M, Winkler G, Glauche V, Liepert J, Heimbach B, Koch MA, Buchel C, Weiller C. Diffusion tensor MRI of early upper motor neuron involvement in amyotrophic lateral sclerosis. Brain. 2004 Feb;127(Pt 2):340-50. doi: 10.1093/brain/awh041. Epub 2003 Nov 7.
Schoenfeld MA, Tempelmann C, Gaul C, Kuhnel GR, Duzel E, Hopf JM, Feistner H, Zierz S, Heinze HJ, Vielhaber S. Functional motor compensation in amyotrophic lateral sclerosis. J Neurol. 2005 Aug;252(8):944-52. doi: 10.1007/s00415-005-0787-y. Epub 2005 Mar 6.
Other Identifiers
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Hum00000219
Identifier Type: -
Identifier Source: secondary_id
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