Healthy SubjectsNCT01517087
Studying Motor Neuron Tests
An observational study of Healthy Subjects and Magnetic Resonance Imaging, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: People with motor neuron disorders have changes in the parts of the brain that control movement. Some tests that are currently used to study these changes are magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS). Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Healthy Subjects, Magnetic Resonance Imaging, Central Nervous System
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2012to 25 Nov 2020
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 55 neurologically normal, healthy adults, age 35 or older.
Who may be able to join
- Healthy adults aged 35 and older
- No history of a neurological disorder
- Able to give informed consent
Who cannot join
- Treatment within the preceding week with medications that affect neuronal excitability, such as antidepressants, sedatives, and drugs for epilepsy or migraine.
- Change in blood pressure medications within the preceding week.
- Metal in the body such as pacemakers, implanted pumps or other implanted electronic devices, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner or shrapnel fragments.
- Pregnancy. Women of childbearing potential will undergo urine pregnancy testing before MRI scanning.
- Fear of confined spaces.
- Serious medical illness.
- Employees or staff in the investigator's section.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Structural and Functional Brain Imaging Markers of Upper Motor Neuron Function
Background:
- People with motor neuron disorders have changes in the parts of the brain that control movement. Some tests that are currently used to study these changes are magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS). We don t know if MRI scans and TMS give the same results if done at different times in the same person. Researchers want to see if these tests produce different results if given to healthy adults on two separate occasions.
Read more
Objectives:
- To test the reliability of different tests of the brain used to study motor neuron disorders.
Eligibility:
- <TAB>Healthy individuals at least 35 years of age who have no history of neurological disorders and take no medications.
- <TAB>Pregnant women may not participate.
Design:
- Participants will be screened with a medical history and physical exam.
- Participants will have two testing visits 1 to 6 months apart.
- The first visit will have three parts. The first part is a neurological exam to test strength, sensation, reflexes, and coordination of movement. The second part will be TMS tests. The third part will involve an MRI scan to study the parts of the brain that control movement.
- At the second visit, participants will have MRI scanning only.
Read the detailed description
Objective
The objective of the protocol is to determine the test-retest reliability of imaging techniques that measure the structural and functional integrity of the motor cortex in healthy subjects. Our goal is to determine whether such measures are sufficiently reproducible that they may be used to follow disease progression over time in patients with motor neuron disease. A second objective is to obtain age-matched normative data to provide reference values for studies examining the correlation of physiological and clinical measurements of motor function, cognitive testing, and plasma and spinal fluid biomarker measures with disease progression in patients with motor neuron disease.
Study Population
55 neurologically normal, healthy adults, age 35 or older
Design
Each subject will undergo several sessions of testing. The first testing session will consist of a clinical examination with measurements of movement speed. Subjects will undergo one session with transcranial magnetic stimulation of the brain, one session of cognitive testing, and three sessions of magnetic resonance imaging of the brain, one to eighteen months apart. Subjects may opt-in for collection of blood and spinal fluid to provide controls for biomarker studies in motor neuron disease patients.
Outcome Measures
The primary outcome is the test-retest reliability of magnetic resonance imaging measurements of the motor cortex in individual subjects.
- Conditions
- Healthy Subjects, Magnetic Resonance Imaging, Central Nervous System, Volunteer, Neurological Disorder
- Keywords
- Cerebrospinal Fluid, Magnetic Resonance Spectroscopy, Transcranial Magnetic Stimulation (TMS), Diffusion Tensor Imaging, Functional Magnetic Resonance Imaging (fMRI), Healthy Volunteer, HV
- Medical subject headings
- Nervous System Diseases
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 |
|---|---|---|
| 1 | neurologically normal, healthy adults, age 35 or older. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test-retest reliability of MRI measures
The test-retest reliability will be assessed by calculating the intraclass correlation coefficient (ICC) between the two sessions. An ICC > 0.8 is considered to indicate excellent reliability.
Measured: 09/30/2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study start1 Feb 2012
- Primary completion25 Nov 2020
- Study completion25 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mary Kay Floeter, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517087
- Sponsor's protocol ID
- 120060
- Other IDs
- 12-N-0060
- Status last verified
- Dec 2020
- First submitted
- 24 Jan 2012
- Last updated
- 12 Mar 2021
- Results posted
- No
Publications
Ellis CM, Simmons A, Jones DK, Bland J, Dawson JM, Horsfield MA, Williams SC, Leigh PN. Diffusion tensor MRI assesses corticospinal tract damage in ALS. Neurology. 1999 Sep 22;53(5):1051-8. doi: 10.1212/wnl.53.5.1051.
PubMed 10496265Tartaglia MC, Laluz V, Rowe A, Findlater K, Lee DH, Kennedy K, Kramer JH, Strong MJ. Brain atrophy in primary lateral sclerosis. Neurology. 2009 Apr 7;72(14):1236-41. doi: 10.1212/01.wnl.0000345665.75512.f9.
PubMed 19349603Wong JC, Concha L, Beaulieu C, Johnston W, Allen PS, Kalra S. Spatial profiling of the corticospinal tract in amyotrophic lateral sclerosis using diffusion tensor imaging. J Neuroimaging. 2007 Jul;17(3):234-40. doi: 10.1111/j.1552-6569.2007.00100.x.
PubMed 17608909Clark MG, Smallwood Shoukry R, Huang CJ, Danielian LE, Bageac D, Floeter MK. Loss of functional connectivity is an early imaging marker in primary lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2018 Nov;19(7-8):562-569. doi: 10.1080/21678421.2018.1517180. Epub 2018 Oct 9.
PubMed 30299161
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Functional Brain Imaging Markers of Upper Motor Neuron Function
- ClinicalTrials.gov ID
- NCT01517087
- Acronym / sponsor ID
- 120060
- Conditions
- Healthy Subjects, Magnetic Resonance Imaging, Central Nervous System, Volunteer, Neurological Disorder
- Keywords
- Cerebrospinal Fluid, Magnetic Resonance Spectroscopy, Transcranial Magnetic Stimulation (TMS), Diffusion Tensor Imaging, Functional Magnetic Resonance Imaging (fMRI), Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 25 Nov 2020 (actual)
- First posted
- 25 Jan 2012 (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.
Background:
- People with motor neuron disorders have changes in the parts of the brain that control movement. Some tests that are currently used to study these changes are magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS). We don t know if MRI scans and TMS give the same results if done at different times in the same person. Researchers want to see if these tests produce different results if given to healthy adults on two separate occasions.
Objectives:
- To test the reliability of different tests of the brain used to study motor neuron disorders.
Eligibility:
- <TAB>Healthy individuals at least 35 years of age who have no history of neurological disorders and take no medications.
- <TAB>Pregnant women may not participate.
Design:
- Participants will be screened with a medical history and physical exam.
- Participants will have two testing visits 1 to 6 months apart.
- The first visit will have three parts. The first part is a neurological exam to test strength, sensation, reflexes, and coordination of movement. The second part will be TMS tests. The third part will involve an MRI scan to study the parts of the brain that control movement.
- At the second visit, participants will have MRI scanning only.
Detailed description
Objective
The objective of the protocol is to determine the test-retest reliability of imaging techniques that measure the structural and functional integrity of the motor cortex in healthy subjects. Our goal is to determine whether such measures are sufficiently reproducible that they may be used to follow disease progression over time in patients with motor neuron disease. A second objective is to obtain age-matched normative data to provide reference values for studies examining the correlation of physiological and clinical measurements of motor function, cognitive testing, and plasma and spinal fluid biomarker measures with disease progression in patients with motor neuron disease.
Study Population
55 neurologically normal, healthy adults, age 35 or older
Design
Each subject will undergo several sessions of testing. The first testing session will consist of a clinical examination with measurements of movement speed. Subjects will undergo one session with transcranial magnetic stimulation of the brain, one session of cognitive testing, and three sessions of magnetic resonance imaging of the brain, one to eighteen months apart. Subjects may opt-in for collection of blood and spinal fluid to provide controls for biomarker studies in motor neuron disease patients.
Outcome Measures
The primary outcome is the test-retest reliability of magnetic resonance imaging measurements of the motor cortex in individual subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –neurologically normal, healthy adults, age 35 or older. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 55 neurologically normal, healthy adults, age 35 or older.
Key inclusion criteria (3 listed)
- Healthy adults aged 35 and older
- No history of a neurological disorder
- Able to give informed consent
Key exclusion criteria (7 listed)
- Treatment within the preceding week with medications that affect neuronal excitability, such as antidepressants, sedatives, and drugs for epilepsy or migraine.
- Change in blood pressure medications within the preceding week.
- Metal in the body such as pacemakers, implanted pumps or other implanted electronic devices, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner or shrapnel fragments.
- Pregnancy. Women of childbearing potential will undergo urine pregnancy testing before MRI scanning.
- Fear of confined spaces.
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
Test-retest reliability of MRI measures
Time frame: 09/30/2019
The test-retest reliability will be assessed by calculating the intraclass correlation coefficient (ICC) between the two sessions. An ICC > 0.8 is considered to indicate excellent reliability.
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 12 Mar 2021.
- Background: PubMed 10496265Ellis CM, Simmons A, Jones DK, Bland J, Dawson JM, Horsfield MA, Williams SC, Leigh PN. Diffusion tensor MRI assesses corticospinal tract damage in ALS. Neurology. 1999 Sep 22;53(5):1051-8. doi: 10.1212/wnl.53.5.1051.
- Background: PubMed 19349603Tartaglia MC, Laluz V, Rowe A, Findlater K, Lee DH, Kennedy K, Kramer JH, Strong MJ. Brain atrophy in primary lateral sclerosis. Neurology. 2009 Apr 7;72(14):1236-41. doi: 10.1212/01.wnl.0000345665.75512.f9.
- Background: PubMed 17608909Wong JC, Concha L, Beaulieu C, Johnston W, Allen PS, Kalra S. Spatial profiling of the corticospinal tract in amyotrophic lateral sclerosis using diffusion tensor imaging. J Neuroimaging. 2007 Jul;17(3):234-40. doi: 10.1111/j.1552-6569.2007.00100.x.
- Derived from this study: PubMed 30299161Clark MG, Smallwood Shoukry R, Huang CJ, Danielian LE, Bageac D, Floeter MK. Loss of functional connectivity is an early imaging marker in primary lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2018 Nov;19(7-8):562-569. doi: 10.1080/21678421.2018.1517180. Epub 2018 Oct 9.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Mary Kay Floeter, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
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 Healthy Subjects and Magnetic Resonance Imaging, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 3 inclusion and 7 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 12 Mar 2021. 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?
Test-retest reliability of MRI measures (time frame: 09/30/2019). 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 NCT01517087, which also lists 4 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 12 Mar 2021.