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.|
|ClinicalTrials.gov Identifier: NCT01517087|
Recruitment Status : Recruiting
First Posted : January 25, 2012
Last Update Posted : March 29, 2018
- 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|
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.
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.
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|
|Official Title:||Structural and Functional Brain Imaging Markers of Upper Motor Neuron Function|
|Study Start Date :||January 9, 2012|
- Test-retest correlation of MRI measures [ Time Frame: ongoing ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517087
|Contact: Carol H Hoffman||(301) firstname.lastname@example.org|
|Contact: Mary Kay Floeter, M.D.||(301) email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||Mary Kay Floeter, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|