- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00809224
Cortex Changes in Real/Imagined Movements in Amyotrophic Lateral Sclerosis (ALS)
Tracking Brain Changes During Real and Imagined Movements in People With ALS (Lou Gehrig's Disease) and Healthy Volunteers.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan, Functional MRI Laboratory
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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ALS
ALS group should have ALS.
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Control
The control group should not have ALS or any other neurological/psychiatric disorder, and must be over the age of 40.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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cortical activation patterns
Time Frame: Yearly
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Yearly
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert Welsh, PhD, Research Assistant Professor, University of Michigan Department of Radiology
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01NS052514 (U.S. NIH Grant/Contract)
- Hum00000219
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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