Muscle Ultrasound Measures as Biomarkers of Upper Motor Neuron Function

NCT02408900 | Completed

• 2 other identifiers: 15010615-N-0106
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Spasticity

Keywords

Spasticity; Primary Lateral Sclerosis; Elastography; Ultrasound

Outcome Measures

Primary Outcomes (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.

  2 years

Secondary Outcomes (1)

• A secondary outcome will be the correlation of muscle stiffness at rest with the modified Ashworth score for elbow flexion.

  2 years

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

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

MeSH Terms

Conditions

Muscle Spasticity; Motor Neuron Disease

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodegenerative Diseases; Neuromuscular 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: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2015
• First Posted: April 6, 2015
• Study Start: March 25, 2015
• Primary Completion: August 3, 2015
• Study Completion: August 3, 2015
• Last Updated: December 17, 2019

Record last verified: 2015-08-03

Locations

US (1)