Ultrasonographic Reference Values for Peripheral Nerves in Children
Overview
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.
Full Title of Study: “Ultrasonographic Reference Values for Peripheral Nerves and Nerve Roots in the Normal Population of Children and Adolescents”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Basic Science
- Masking: None (Open Label)
- Study Primary Completion Date: December 2021
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.
Interventions
- Procedure: Ultrasonographic examination
Arms, Groups and Cohorts
- Other: ultrasound of peripheral nerves
- Ultrasonographic examination
Clinical Trial Outcome Measures
Primary Measures
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Secondary Measures
- Interrater reliability
- Time Frame: one year
- Reliability is expressed by the intraclass correlation coefficient (ICC)
- Intrarater reliability
- Time Frame: one year
- Reliability is expressed by the intraclass correlation coefficient (ICC)
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 2 Years
Maximum Age: 18 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- University Hospital, Basel, Switzerland
- Collaborator
- University Children’s Hospital Basel
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Dirk Fischer, MD, Principal Investigator, University of Basel, Children’s Hospital
- Overall Contact(s)
- Patricia Hafner, MD, +41617042272, patricia.hafner@ukbb.ch
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