NCT02570802

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
255

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2015

Completed
17 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 23, 2024

Status Verified

May 1, 2024

Enrollment Period

9.2 years

First QC Date

September 14, 2015

Last Update Submit

May 22, 2024

Conditions

Normal Values of Peripheral Nerves in Healthy Children

Outcome Measures

Primary Outcomes (9)

  • Cross-sectional area (mm2) of the C5 cervical root in children and adolescents from 2 to 18 years

    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

    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

    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

    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

    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

    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

    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

    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

    Cross-sectional area will be displayed as percentiles according age, weight and length

    one year

Secondary Outcomes (2)

  • Interrater reliability

    one year

  • Intrarater reliability

    one year

Study Arms (1)

ultrasound of peripheral nerves

OTHER

Ultrasonographic examination

Procedure: Ultrasonographic examination

Interventions

Ultrasonographic examinationPROCEDURE
ultrasound of peripheral nerves

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Inability to meet study requirements
  • Neuromuscular disease or symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Basel, Children's Hospital

Basel, 4056, Switzerland

RECRUITING

Related Publications (1)

  • Rasenack M, Decard BF, Schadelin S, Grimm A, Fischer D, Hafner P. Ultrasonographic reference values for peripheral nerves and nerve roots in the normal population of children and adolescents: study protocol for an observational-prospective trial. BMJ Open. 2016 Dec 9;6(12):e014662. doi: 10.1136/bmjopen-2016-014662.

    PMID: 27940636DERIVED

Study Officials

  • Dirk Fischer, MD

    University of Basel, Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Hafner, MD

CONTACT

+41617042272patricia.hafner@ukbb.ch

Maria Rasenack, MD

CONTACT

+41612652525maria.rasenack@usb.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2015

First Posted

October 7, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

May 23, 2024

Record last verified: 2024-05

Locations

CH(1)