Collecting Normative Data of Ulnar Nerve CSAUS-ULNNCT06818162
MULTICENTER ULNAR NERVE ULTRASONOGRAPHIC and NEUROPHYSIOLOGICAL STUDY: NORMATIVE DATA COLLECTION
An observational study of Collecting Normative Data of Ulnar Nerve CSA, run by IRCCS San Raffaele.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Collecting Normative Data of Ulnar Nerve CSA
- What is being tested?
- normative data
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with indication to perform an EMG/ENG for upper limb which fulfill inclusion/exclusion criteria
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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).
- Being tested
- normative data
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normative dataOther
Ultra sonography of ulnar nerve along its course to obtain normative values for the CSA
What is being measured
The primary outcome is the main question the study is designed to answer.
CSA Normative value
CSA Normative value of ulnar nerve at the wrist, below, at, above the elbow, at Axilla, CSA above elbow/CSA below elbow ratio
Measured: single evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study startMar 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Collecting Normative Data of Ulnar Nerve CSAStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ubaldo Del Carro, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818162
- Sponsor's protocol ID
- US-ULN
- Acronym
- US-ULN
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MULTICENTER ULNAR NERVE ULTRASONOGRAPHIC and NEUROPHYSIOLOGICAL STUDY: NORMATIVE DATA COLLECTION
- ClinicalTrials.gov ID
- NCT06818162
- Acronym / sponsor ID
- US-ULN / US-ULN
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with indication to perform an EMG/ENG for upper limb which fulfill inclusion/exclusion criteria
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| normative dataUltra sonography of ulnar nerve along its course to obtain normative values for the CSA | Other | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Collecting Normative Data of Ulnar Nerve CSA, run by IRCCS San Raffaele.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ubaldo Del Carro (+39 02 2643 3092, delcarro.ubaldo@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSA Normative value (time frame: single evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.