ALSNCT00809224
Cortex Changes in Real/Imagined Movements in Amyotrophic Lateral Sclerosis (ALS)
An observational study of ALS and Amyotrophic Lateral Sclerosis, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- ALS, Amyotrophic Lateral Sclerosis
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All are able to participate.
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan, Functional MRI Laboratory
Ann Arbor, Michigan, 48109
About this study
Official title: Tracking Brain Changes During Real and Imagined Movements in People With ALS (Lou Gehrig's Disease) and Healthy Volunteers.
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.
Read the 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.
- Conditions
- ALS, Amyotrophic Lateral Sclerosis
- Keywords
- ALS, amyotrophic lateral sclerosis, brain-computer interface, functional magnetic resonance imaging, radiology, fMRI
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cortical activation patterns
Measured: Yearly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ALSStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Welsh, University of Michigan
- Investigators
- Robert Welsh, PhD, Principal investigator, Research Assistant Professor, University of Michigan Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809224
- Sponsor's protocol ID
- R01NS052514
- Other IDs
- Hum00000219
- Status last verified
- May 2016
- First submitted
- 15 Dec 2008
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 15163610Biswal 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.
PubMed 9430343Brooks 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.
PubMed 11464937Havel 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.
PubMed 16283098Jacob 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.
PubMed 12904924Konrad 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.
PubMed 11907690Konrad 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.
PubMed 16463149Sach 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.
PubMed 14607785Schoenfeld 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.
PubMed 15750701
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking Brain Changes During Real and Imagined Movements in People With ALS (Lou Gehrig's Disease) and Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT00809224
- Acronym / sponsor ID
- R01NS052514
- Conditions
- ALS, Amyotrophic Lateral Sclerosis
- Keywords
- ALS, amyotrophic lateral sclerosis, brain-computer interface, functional magnetic resonance imaging, radiology, fMRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- May 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 17 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All are able to participate.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cortical activation patterns
Time frame: Yearly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- Background: PubMed 15163610Abrahams 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.
- Background: PubMed 9430343Biswal 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.
- Background: PubMed 11464937Brooks 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.
- Background: PubMed 16283098Havel 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.
- Background: PubMed 12904924Jacob 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.
- Background: PubMed 11907690Konrad 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.
- Background: PubMed 16463149Konrad 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.
- Background: PubMed 14607785Sach 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.
- Background: PubMed 15750701Schoenfeld 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Welsh, PhD principal investigator
Research Assistant Professor, University of Michigan Department of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ALS and Amyotrophic Lateral Sclerosis, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cortical activation patterns (time frame: Yearly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00809224, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016.