Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Studying Motor Neuron Tests

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier:
NCT01517087
First received: January 24, 2012
Last updated: November 11, 2014
Last verified: September 2014
  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:

  • < 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.

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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Test-retest correlation of MRI measures

Estimated Enrollment: 45
Study Start Date: January 2012
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 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

5545 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
Criteria
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517087

Contacts
Contact: Carol H Hoffman (301) 496-7428 carol.hoffman@nih.gov
Contact: Mary Kay Floeter, M.D. (301) 496-7428 floeterm@ninds.nih.gov

Locations
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   
Sponsors and Collaborators
Investigators
Principal Investigator: Mary Kay Floeter, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier: NCT01517087     History of Changes
Other Study ID Numbers: 120060, 12-N-0060
Study First Received: January 24, 2012
Last Updated: November 11, 2014
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 November 27, 2014