Ultrasonographic Reference Values for Peripheral Nerves in Children

December 1, 2020 updated by: University Hospital, Basel, Switzerland

Ultrasonographic Reference Values for Peripheral Nerves and Nerve Roots in the Normal Population of Children and Adolescents

The purpose of this clinical trial is to assess normal values of the cross-sectional area of peripheral nerves and nerve roots in children and adolescents between 2 and 18 years.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a single center prospective clinical trial to determine standard values of the cross-sectional area of the median, ulnar, radial, peroneal, tibial, sural and vagus nerve as well as C5, C6 and C7 cervical roots in a cohort of neuromuscular unaffected children and adolescents between 2 and 18 years.

Study Type

Interventional

Enrollment (Anticipated)

255

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children and adolescents between 2 and 18 years
  • Written informed consent of the caregivers and the children/adolescents between 14 and 18 years

Exclusion Criteria:

  • Inability to meet study requirements
  • Neuromuscular disease or symptoms

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

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ultrasound of peripheral nerves
Ultrasonographic examination
Procedure: Ultrasonographic examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cross-sectional area (mm2) of the C5 cervical root in children and adolescents from 2 to 18 years
Time Frame: one year
Cross-sectional area will be displayed as percentiles according age, weight and length
one year
Cross-sectional area (mm2) of the C6 cervical root in children and adolescents from 2 to 18 years
Time Frame: one year
Cross-sectional area will be displayed as percentiles according age, weight and length
one year
Cross-sectional area (mm2) of the C7 cervical root in children and adolescents from 2 to 18 years
Time Frame: one year
Cross-sectional area will be displayed as percentiles according age, weight and length
one year
Cross-sectional area (mm2) of the radial nerve in children and adolescents from 2 to 18 years
Time Frame: one year
Cross-sectional area will be displayed as percentiles according age, weight and length
one year
Cross-sectional area (mm2) of the superficial radial nerve in children and adolescents from 2 to 18 years
Time Frame: one year
Cross-sectional area will be displayed as percentiles according age, weight and length
one year
Cross-sectional area (mm2) of the peroneal nerve in children and adolescents from 2 to 18 years
Time Frame: one year
Cross-sectional area will be displayed as percentiles according age, weight and length
one year
Cross-sectional area (mm2) of the tibial nerve in children and adolescents from 2 to 18 years
Time Frame: one year
Cross-sectional area will be displayed as percentiles according age, weight and length
one year
Cross-sectional area (mm2) of the sural nerve in children and adolescents from 2 to 18 years
Time Frame: one year
Cross-sectional area will be displayed as percentiles according age, weight and length
one year
Cross-sectional area (mm2) of the vagus nerve in children and adolescents from 2 to 18 years
Time Frame: one year
Cross-sectional area will be displayed as percentiles according age, weight and length
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interrater reliability
Time Frame: one year
Reliability is expressed by the intraclass correlation coefficient (ICC)
one year
Intrarater reliability
Time Frame: one year
Reliability is expressed by the intraclass correlation coefficient (ICC)
one year

Collaborators and Investigators

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

Sponsor

University Hospital, Basel, Switzerland

Collaborators

University Children's Hospital Basel

Investigators

  • Principal Investigator: Dirk Fischer, MD, University of Basel, Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2015

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

September 14, 2015

First Submitted That Met QC Criteria

October 5, 2015

First Posted (Estimate)

October 7, 2015

Study Record Updates

Last Update Posted (Actual)

December 2, 2020

Last Update Submitted That Met QC Criteria

December 1, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Nerve US Children 01

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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