Neuromuscular Ultrasound in Correlation to Neurophysiological Findings

September 17, 2019 updated by: Shahera Sayed Ahmed Abd El Maged, Assiut University

Neuromuscular Ultrasound Changes in Neuropathies in Correlation to Neurophysiological Findings

  1. Study the neuromuscular ultrasound findings in different types of neuropathies
  2. correlation between ultrasound and neurophysiological findings in peripheral nerve diseases
  3. correlation between clinical pain scale and severity of neuropathy

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Ultrasonography is a diagnostic tool that is increasingly used in the work-up of peripheral nerve disease.

As many peripheral nerves run a superficial course, especially in the arms. This is a big advantage over Magnetic Resonance Imaging that is relatively expensive, time consuming and not readily available everywhere.

Nerve cross-sectional area (CSA) can be determined at multiple sites along the nerve.

CSA can be measured at entrapment sites but also at nonentrapment sites. vascularization, echogenicity, fascicular pattern and endoneurial thickness can be investigated as well. All those modalities can give critical insight in the origin and development of various peripheral neuropathies1,2,3

Major peripheral nerves in the extremities, such as the median,ulnar thick enough to reflect the sound beam, resulting in hyperechoic on the US scan 4.

The correlation between nerve conduction study parameters and CSA in ultrasound Ultrasound of the peripheral nervous system is an additional useful diagnostic tool in neuromuscular disorders..5,6,7,8,9 In the longitudinal plane, nerves present as long, slim structures with a mixture of parallel hypoechoic and hyperechoic lines.

Nerves must be distinguished from other nearby structures to ensure correct identification Muscles are hypoechoic and interspersed with small hyperechoic foci which easily distinguishes muscles from nerves. Tendons, which are sometimes adjacent to nerves, move proportionately with joint movement.

US has higher specificity than sensitivity in differentiating myopathic and neuropathic changes The most sensitive diagnostic marker for symptomatic carpal tunnel syndrome patients is an enlarged crosssectional area of the median nerve 10,11,12

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Setting:in assuit university hospitals, neuropsychiatry hospital,neurology, orthopedic ,and internal medicine outpatients clinics subjects:will include two groups : peripheral nerve diseases group and healthy control group

Description

Inclusion Criteria:

  • above 18 years old
  • males or females
  • diabetic complaining of neuropathy or not
  • carpal tunnel syndrome
  • Guillain-Barré syndrome

Exclusion Criteria:

  • Patient refuse to participate
  • The anatomy is altered due to sever trauma,tumor,or surgery
  • Severe spasticity preventing examination

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
diabetic complaining of neuropathy or not
using of ultrasound in examination and nerve conduction study
Device: ultrasound
easy new non invasive tool
Other Names:
  • ultrasonography
carpal tunnel syndrome
using of ultrasound in examination and nerve conduction study
Device: ultrasound
easy new non invasive tool
Other Names:
  • ultrasonography

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Nerve ultrasound
Time Frame: 3 years
on median and ulnar nerves
3 years
muscle Ultrasound
Time Frame: 3 years
on thenar and hypothenar muscles
3 years
nerve conduction studies
Time Frame: 3 years
for median and ulnar nerves (sensory and motor)
3 years
Electromyogram
Time Frame: 3 years
for thenar and hypothenar
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ultrasound in neuropathies

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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