Cortex Changes in Real/Imagined Movements in Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Tracking Brain Changes During Real and Imagined Movements in People With ALS (Lou Gehrig's Disease) and Healthy Volunteers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809224
• Other study ID #: R01NS052514
• Secondary ID: Hum00000219
• Status: Completed
• Phase: N/A
• First received: December 15, 2008
• Last updated: May 12, 2016
• Start date: May 2008
• Est. completion date: May 2012

Study information

• Verified date: May 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Observational Model: Case Control

Related Conditions & MeSH terms

• ALS
• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Locations

Country	Name	City	State
United States	University of Michigan, Functional MRI Laboratory	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. Epub 2004 May 26. — View Citation

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. — View Citation

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. Review. — View Citation

Havel P, Braun B, Rau S, Tonn JC, Fesl G, Brückmann H, Ilmberger J. Reproducibility of activation in four motor paradigms. An fMRI study. J Neurol. 2006 Apr;253(4):471-6. Epub 2005 Nov 14. — View Citation

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. Epub 2003 Aug 7. — View Citation

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. Epub 2002 Jan 24. — View Citation

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. Epub 2006 Mar 25. — View Citation

Sach M, Winkler G, Glauche V, Liepert J, Heimbach B, Koch MA, Büchel C, Weiller C. Diffusion tensor MRI of early upper motor neuron involvement in amyotrophic lateral sclerosis. Brain. 2004 Feb;127(Pt 2):340-50. Epub 2003 Nov 7. — View Citation

Schoenfeld MA, Tempelmann C, Gaul C, Kühnel GR, Düzel 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. Epub 2005 Mar 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cortical activation patterns		Yearly	No

External Links

•   The Welsh Lab Group Website
•   University of Michigan Functional MRI Laboratory