Studying Motor Neuron Tests
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Purpose
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:
- Healthy individuals at least 35 years of age who have no history of neurological disorders and take no medications.
- 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.
| Condition |
|---|
|
Magnetic Resonance Imaging Central Nervous System Volunteer Neurological Disorder |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Structural and Functional Brain Imaging Markers of Upper Motor Neuron Function |
| Estimated Enrollment: | 45 |
| Study Start Date: | January 2012 |
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 on physiological and clinical measurements of motor function to provide reference values for future studies examining the correlation of these measures with disease progression in patients with motor neuron disease.
Study Population
45 neurologically normal, healthy adults, age 35 or older
Design
Each subject will undergo four sessions of testing. The first testing session will consist of a clinical examination with measurements of movement speed and transcranial magnetic stimulation of the brain. Two sessions will consist of magnetic resonance imaging of the brain, one to six months apart. One session will consist of magnetic resonance scanning of the spinal cord.
Outcome Measures
The primary outcome is the test-retest reliability of magnetic resonance spectroscopy measurements of N-acetylaspartate (NAA) in the hand region of the motor cortex in individual subjects.
Eligibility| Ages Eligible for Study: | 35 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
- INCLUSION CRITERIA:
- Healthy adults aged 35 and older
- No history of a neurological disorder
- Able to give informed consent
EXCLUSION CRITERIA:
- 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.
Contacts and Locations| Contact: Carol H Hoffman | (301) 496-7428 | carol.hoffman@nih.gov |
| Contact: Mary Kay Floeter, M.D. | (301) 496-7428 | floeterm@ninds.nih.gov |
| 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 Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
| Principal Investigator: | Mary Kay Floeter, M.D. | National Institute of Neurological Disorders and Stroke (NINDS) |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT01517087 History of Changes |
| Other Study ID Numbers: | 120060, 12-N-0060 |
| Study First Received: | January 24, 2012 |
| Last Updated: | December 19, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Motor Function Magnetic Resonance Spectroscopy Transcranial Magnetic Stimulation (TMS) Diffusion Tensor Imaging |
Functional Magnetic Resonance Imaging (fMRI) Healthy Volunteer HV |
Additional relevant MeSH terms:
|
Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013