Studying Motor Neuron Tests

NCT01517087 | Completed

• 2 other identifiers: 12006012-N-0060
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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). 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  09/30/2019

Study Arms (1)

1

neurologically normal, healthy adults, age 35 or older.

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

55 neurologically normal, healthy adults, age 35 or older.

You may qualify if:

• Healthy adults aged 35 and older
• No history of a neurological disorder
• Able to give informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• 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.

  PMID: 10496265 BACKGROUND

• Tartaglia 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.

  PMID: 19349603 BACKGROUND

• Wong 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.

  PMID: 17608909 BACKGROUND

• Clark 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.

  PMID: 30299161 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Nervous System Diseases

Study Officials

• Mary Kay Floeter, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: January 25, 2012
• Study Start: February 1, 2012
• Primary Completion: November 25, 2020
• Study Completion: November 25, 2020
• Last Updated: March 12, 2021

Record last verified: 2020-12

Locations

US (1)