Muscle SpasticityNCT02408900
Muscle Ultrasound Measures as Biomarkers of Upper Motor Neuron Function
An observational study of Muscle Spasticity, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Muscle Spasticity
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2015to 3 Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Mechanical limitation of elbow flexion
- Achilles tendon surgical procedures
- History of cervical radiculopathy
- History of botulinum injections
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Pilot Study of Muscle Ultrasound Measures as Biomarkers of Upper Motor Neuron Function
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.
Read more
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.
Read the 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.
- Conditions
- Muscle Spasticity
- Keywords
- Spasticity, Primary Lateral Sclerosis, Elastography, Ultrasound
- Medical subject headings
- Muscle Spasticity, Motor Neuron Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study start25 Mar 2015
- Primary completion3 Aug 2015
- Study completion3 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle SpasticityStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mary Kay Floeter, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408900
- Sponsor's protocol ID
- 150106
- Other IDs
- 15-N-0106
- Status last verified
- 3 Aug 2015
- First submitted
- 3 Apr 2015
- Last updated
- 17 Dec 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Muscle Ultrasound Measures as Biomarkers of Upper Motor Neuron Function
- ClinicalTrials.gov ID
- NCT02408900
- Acronym / sponsor ID
- 150106
- Conditions
- Muscle Spasticity
- Keywords
- Spasticity, Primary Lateral Sclerosis, Elastography, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 25 Mar 2015
- Primary completion
- 3 Aug 2015 (actual)
- Study completion
- 3 Aug 2015 (actual)
- First posted
- 6 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- Mechanical limitation of elbow flexion
- Achilles tendon surgical procedures
- History of cervical radiculopathy
- History of botulinum injections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
A secondary outcome will be the correlation of muscle stiffness at rest with the modified Ashworth score for elbow flexion.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
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Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
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Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
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Spasticity, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Kay Floeter, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Spasticity, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.