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NCT Number: NCT06818162

MULTICENTER ULNAR NERVE ULTRASONOGRAPHIC and NEUROPHYSIOLOGICAL STUDY: NORMATIVE DATA COLLECTION

The study population will include a total of 500 subjects, selected from outpatients accessing the Neurophysiology Service for a neurophysiological study of the upper limbs. Only those whose neurophysiological examination results negative for Peripheral Nervous System pathology (i.e., negative electroneurography and electromyography according to AANEM guidelines) will be recruited. The subjects will be enrolled in 22 centers distributed throughout Italy, with our center planning to recruit 50 subjects.

The diagnostic procedures include electroneurography and electromyography, which are standard clinical practice. Ultrasound (ultrasonographic study) is not an experimental technique but is considered an additional procedure specifically included in the study protocol.

The primary objective of the study is to establish normative values for the CSA of the ulnar nerve and assess the reliability of the measurement through inter-operator comparison (between a physician and a neurophysiology technician). Therefore, during an evaluation lasting approximately 30-60 minutes, the enrolled subjects will undergo an electroneurographic/electromyographic and ultrasound study of the ulnar nerve. The latter will be performed by two independent operators (a physician and a neurophysiology technician).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over 18 years old EMG/ENG completely negative for pathologies of the peripheral nervous system (ENG and EMG negative according to the regulatory data of each single Center) Signature of the informed consent

Exclusion criteria

  • Diabetes, Hepatitis, Renal Failure History of NPL or previous CT Previous pathologies of the peripheral nervous system Previous trauma to the limb in question Positive familiarity for neuromuscular disorders

Treatment and study plan

normative data

Other

Ultra sonography of ulnar nerve along its course to obtain normative values for the CSA

Primary outcomes

  1. CSA Normative value

    Time frame: single evaluation

    CSA Normative value of ulnar nerve at the wrist, below, at, above the elbow, at Axilla, CSA above elbow/CSA below elbow ratio

Study contacts

Contact information is provided by the study sponsor or research team.

Ubaldo Del Carro

CONTACT

[email protected]

+39 02 2643 3092

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Acronym: US-ULN

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2025
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.