NCT00809224

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 16, 2016

Status Verified

May 1, 2016

Enrollment Period

4 years

First QC Date

December 15, 2008

Last Update Submit

May 12, 2016

Conditions

Keywords

ALSamyotrophic lateral sclerosisbrain-computer interfacefunctional magnetic resonance imagingradiologyfMRI

Outcome Measures

Primary Outcomes (1)

  • cortical activation patterns

    Yearly

Study Arms (2)

ALS

ALS group should have ALS.

Control

The control group should not have ALS or any other neurological/psychiatric disorder, and must be over the age of 40.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All are able to participate.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan, Functional MRI Laboratory

Ann Arbor, Michigan, 48109, United States

Location

Related 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. doi: 10.1093/brain/awh170. Epub 2004 May 26.

    PMID: 15163610BACKGROUND
  • 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.

    PMID: 9430343BACKGROUND
  • 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.

    PMID: 11464937BACKGROUND
  • 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.

    PMID: 16283098BACKGROUND
  • 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.

    PMID: 12904924BACKGROUND
  • 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.

    PMID: 11907690BACKGROUND
  • 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.

    PMID: 16463149BACKGROUND
  • 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.

    PMID: 14607785BACKGROUND
  • 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.

    PMID: 15750701BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Robert Welsh, PhD

    Research Assistant Professor, University of Michigan Department of Radiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

December 15, 2008

First Posted

December 17, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

May 16, 2016

Record last verified: 2016-05

Locations