Studying Motor Neuron Tests

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01517087
Recruitment Status : Recruiting
First Posted : January 25, 2012
Last Update Posted : March 29, 2018
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Brief Summary:


- 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.


- To test the reliability of different tests of the brain used to study motor neuron disorders.


  • <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.


  • 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.

Condition or disease
Magnetic Resonance Imaging Central Nervous System Volunteer Neurological Disorder

Detailed Description:


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


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 Type : Observational
Estimated Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Structural and Functional Brain Imaging Markers of Upper Motor Neuron Function
Study Start Date : January 9, 2012

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Test-retest correlation of MRI measures [ Time Frame: ongoing ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
  • Healthy adults aged 35 and older
  • No history of a neurological disorder
  • Able to give informed consent


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01517087

Contact: Carol H Hoffman (301) 451-1229
Contact: Mary Kay Floeter, M.D. (301) 496-7428

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Mary Kay Floeter, M.D. National Institute of Neurological Disorders and Stroke (NINDS)

Additional Information:
Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS) Identifier: NCT01517087     History of Changes
Other Study ID Numbers: 120060
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: January 10, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Motor Function
Magnetic Resonance Spectroscopy
Transcranial Magnetic Stimulation (TMS)
Diffusion Tensor Imaging
Functional Magnetic Resonance Imaging (fMRI)
Healthy Volunteer

Additional relevant MeSH terms:
Nervous System Diseases