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Muscle Ultrasound Measures as Biomarkers of Upper Motor Neuron Function

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ClinicalTrials.gov Identifier: NCT02408900
Recruitment Status : Completed
First Posted : April 6, 2015
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Brief Summary:

Background:

- Primary lateral sclerosis (PLS) is a rare disease. It leads to weakness in the muscle of the arms, legs, and face. People with PLS develop muscle stiffness called spasticity. Researchers want to find a better way to measure this. They want to see if ultrasound, which uses sound waves to look at parts of the body, can measure spasticity and stiffness in muscles.

Objective:

- To see if ultrasound can detect and measure muscle spasticity in people with PLS.

Eligibility:

  • People ages 18 75 who have a diagnosis of PLS and are enrolled in protocol 01-N-0145.
  • Healthy volunteers ages 18 75.

Design:

  • Participants with PLS will have 1 study visit. Healthy participants will have upto 5 visits. Each visit will be about 2 hours.
  • Participants will have tests of muscle strength. They will be examined. They will push their arms and legs against researchers in different positions.
  • Participants will have tests of muscle stiffness. Their arms and legs will be moved while they relax.
  • Participants will have a muscle ultrasound test. They will lie on a table. Gel will be placed on the skin over the muscles of the arms and legs. A probe, like a microphone, will be moved over the skin. Researchers will look at several muscles.
  • Participants should try to stay still during the ultrasound. It may be done several times and may be done by different examiners.

Condition or disease
Muscle Spasticity

Detailed Description:

Objective

Persons with corticospinal, or upper motor neuron dysfunction have increased muscle stiffness from spasticity. Spasticity is established by clinical examination, but there are few reliable objective measures of spasticity. New ultrasound techniques to measure the elastic properties of tissue represent a potential measure of spasticity. The ultrasound measures of tissue elasticity are painless and quick to perform, but their ability to detect changes resulting from spasticity is uncertain. The goal of this pilot study is to see how much ultrasound measures of muscle elasticity differ between patients with spasticity and healthy controls. Secondary objectives are to correlate muscle elasticity measures with a clinical rating scale of spasticity and to assess intra and inter-rater reliability. This is a protocol for primary lateral sclerosis (PLS) patients who are enrolled in another NIH study in which they have been diagnosed with spasticity.

Study Population

23 adult PLS patients with arm or leg spasticity currently enrolled in an NIH protocol

30 healthy adult controls with normal neurological exams.

Design

The first phase, an investigator training phase, is aimed to become familiar with the Siemens Acuson S2000 after the upgrade. The two investigators will train with 5 healthy volunteers. In the second phase inter-observer variability of the ultrasound and Ashworth scale will be assessed by having healthy volunteers and patients evaluated by the different investigators. Since spasticity does fluctuate throughout the day, subjects will be consecutively assessed for inter-observer variability and within a few hours or around the same time the following day (depending on patient availability) for intra-observer variability. Each investigator will do the Ashworth scale independent of the other. Each investigator will do the ultrasound independent of the other. In the third phase, we will assess patients and volunteers to reach the sample size that a power analysis suggested that we would need to measure differences between patients with spasticity and controls.

Outcome Measures

The primary outcome will be measuring muscle stiffness from the biceps brachii using ultrasound elastography, which will be compared between patient groups and control groups. A secondary outcome will be the correlation of muscle stiffness at rest with the modified Ashworth score for elbow flexion. Measures of muscle strength and ultrasound measures of density and thickness will be examined in an exploratory fashion. Elastography of the tibialis anterior will be examined in an exploratory fashion.

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Pilot Study of Muscle Ultrasound Measures as Biomarkers of Upper Motor Neuron Function
Study Start Date : March 25, 2015
Actual Primary Completion Date : August 3, 2015
Actual Study Completion Date : August 3, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound




Primary Outcome Measures :
  1. The primary outcome will be measuring muscle stiffness from the biceps brachii using ultrasound elastography, which will be compared between patient groups and control groups. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. A secondary outcome will be the correlation of muscle stiffness at rest with the modified Ashworth score for elbow flexion. [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:<TAB>

Healthy Controls

  • Adults between ages of 18-75; matched to the patient cohort
  • No history of neurological disorder
  • No use of medications that produce muscle relaxation within 1 week of study, such as baclofen, cyclobenzaprine, or tizanidine.
  • Able to give informed consent

Patients

  • Adults between ages of 18-75
  • A clinical diagnosis of primary lateral sclerosis determined in NIH protocol 01-N-0145.
  • No contractures of arms and legs
  • Able to give informed consent

EXCLUSION CRITERIA:

  • Mechanical limitation of elbow flexion
  • Achilles tendon surgical procedures
  • History of cervical radiculopathy
  • History of botulinum injections

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 ClinicalTrials.gov identifier (NCT number): NCT02408900


Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Mary Kay Floeter, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
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Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT02408900    
Other Study ID Numbers: 150106
15-N-0106
First Posted: April 6, 2015    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: August 3, 2015
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Spasticity
Primary Lateral Sclerosis
Elastography
Ultrasound
Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases