Electrophysiological Study of Berrettini Anastomosis

June 12, 2024 updated by: Alberto Cappellari, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

The common opinion that sensory supply of digit 5 (D5) and medial half of digit 4 (D4) of the hand is by ulnar nerve, while the lateral half of D4 and the remaining digits is by median nerve is an oversimplification of a complex topic. Indeed, the literature demonstrated that both the median and ulnar nerves display a number of deviations to the traditionally taught branching patterns.

The aim of our study was to investigate the physiological role of median and ulnar nerves in the sensory supply of D4.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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 Locations

  • Italy
      • Milan, Italy
        • Pediatric Emergency Department Clinica de Marchi, Foundation IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • age 24-60 years
  • male and female
  • under informed consent
  • no history of previous neuromuscular disease and no abnormalities on neurological examination

Exclusion Criteria:

-

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: 30 healthy subjects with no history of neuromuscular disease
30 healthy subjects with no history of previous neuromuscular disease and no abnormalities on neurological examination
Other: electrophysiological study
Antidromic sensory nerve conduction studies of median and ulnar nerves will be performed on both hands of 30 healthy subjects with no history of previous neuromuscular disease and no abnormalities on neurological examination., by using surface electrical stimulation at wrist and surface digital recording electrodes on both sides of D4.
Device: electromyograph
surface electrical stimulation at wrist and surface digital recording electrodes on both sides of D4.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
analysis of the sensory potential (UV amplitude in MSEC) recorded on both sides of the IV finger of the hand by stimulation of the median nerve and the ulnar one
Time Frame: immediately after the procedure
immediately after the procedure
analysis of the sensory potential ( latency in MSEC) recorded on both sides of the IV finger of the hand by stimulation of the median nerve and the ulnar one
Time Frame: immediately after the procedure
immediately after the procedure

Collaborators and Investigators

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

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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 (Actual)

January 25, 2024

Primary Completion (Actual)

February 15, 2024

Study Completion (Actual)

March 15, 2024

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

June 12, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 12, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • MANOSENS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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