Electrophysiologic StudyNCT06458751
Electrophysiological Study of Berrettini Anastomosis
A study testing electrophysiological study and electromyograph in people with Electrophysiologic Study and Hand Anastomosis, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 24 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Electrophysiologic Study, Hand Anastomosis
- What is being tested?
- electrophysiological study and electromyograph
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 25 Jan 2024to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 24 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 24-60 years
- male and female
- under informed consent
- no history of previous neuromuscular disease and no abnormalities on neurological examination
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Italy1 site
Pediatric Emergency Department Clinica de Marchi, Foundation IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan
About this study
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.
- Conditions
- Electrophysiologic Study, Hand Anastomosis
- Being tested
- electrophysiological study, electromyograph
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrophysiological studyOther
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.
electromyographDevice
surface electrical stimulation at wrist and surface digital recording electrodes on both sides of D4.
| Study group | Role | What they receive |
|---|---|---|
| 30 healthy subjects with no history of neuromuscular disease | Other | 30 healthy subjects with no history of previous neuromuscular disease and no abnormalities on neurological examination Receives: Other: electrophysiological study; Device: electromyograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start25 Jan 2024
- Primary completion15 Feb 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electrophysiologic StudyStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Cappellari, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458751
- Sponsor's protocol ID
- MANOSENS
- Status last verified
- Jun 2024
- First submitted
- 22 May 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Study of Berrettini Anastomosis
- ClinicalTrials.gov ID
- NCT06458751
- Acronym / sponsor ID
- MANOSENS
- Conditions
- Electrophysiologic Study, Hand Anastomosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 14 Jun 2024 (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 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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 30 healthy subjects with no history of neuromuscular disease | Other | Other: electrophysiological study, Device: electromyograph30 healthy subjects with no history of previous neuromuscular disease and no abnormalities on neurological examination |
Who may qualify
- Ages
- 24 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 24-60 years
- male and female
- under informed consent
- no history of previous neuromuscular disease and no abnormalities on neurological examination
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| electrophysiological studyAntidromic 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. | Other | 30 healthy subjects with no history of neuromuscular disease |
| electromyographsurface electrical stimulation at wrist and surface digital recording electrodes on both sides of D4. | Device | 30 healthy subjects with no history of neuromuscular disease |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrophysiological study and electromyograph in people with Electrophysiologic Study and Hand Anastomosis, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 4 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: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. 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 14 Jun 2024.