PolyneuropathiesNCT06390527
Ultrasonography in Diagnosis of Polyneuropathy
An observational study of Polyneuropathies, run by University Medical Centre Ljubljana.
Trial summary
The main goal of this trial is to establish recommendations for clinical practice that enhance the reliability, accessibility and convenience of sheer wave elastography as a routine diagnostic test for diverse peripheral neuropathies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Polyneuropathies
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Feb 2027
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with peripheral polyneuropathy recruited from the electronic database at the institute of Clinical Neurophysiologym Division of Neurology, University Medical Centre Ljubljana, Slovenia, and distributed in groups with different types of polyneuropathy.
Who may be able to join
- Age 18-80 years
- Clinical signs of particular polyneuropathy not explained by other causes
Who cannot join
- Entrapment or compression neuropathies
- Nerve trauma
- The diagnosis of vasculitic neuropathy, neuralgic amyotrophy, diabetic radiculo-plexo-neuropathy, hereditary neuropathy with liability to pressure palsies and motor neuron disorders including monomelic amyotrophy.
About this study
Official title: Optimization of Ultrasound Sheer Wave Elastography for the Evaluation of Peripheral Nerve Disorders
The main goal of this trial is to establish recommendations for clinical practice that enhance the reliability, accessibility and convenience of sheer wave elastography as a routine diagnostic test for diverse peripheral neuropathies.
- Conditions
- Polyneuropathies
- Medical subject headings
- Polyneuropathies
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical examination
- Myotatic reflexes (biceps, triceps, finger flexors, patellar, Achilles, deep abdominal): 1-absent, 2-reduced or 3-present with facilitation.
- Muscle atrophy: 1-no atrophy, 2-mild, 3-moderate or4-severe atrophy
- Muscle strength of lower and upper limbs with Medical Research Council (MRC) scale (0-5/5): shoulder abduction, elbow flexion and extension, wrist flexion and extension, fingers flexion, extension and abduction, hip flexion, extension, abduction and adduction, knee flexion and extension, ankle dorsal flexion, plantar flexion, eversion and inversion, thumb flexion and extension.
- Touch sensation in all dermatomes with cotton wool: 1-normal sensation, 2-mild, 3-severe or 4-absent.
Measured: Through study completion, an average 2 years.
Electrodiagnostic studies
- Motor nerve conduction studies in median, ulnar, radial, fibular and tibial: distal motor latency, compound muscle action potential (CMAP) amplitude, duration and area, conduction velocity.
- Sensory nerve conduction studies in median, ulnar, superficial radial, superficial fibular and sural nerve: latency, sensory nerve action potential (SNAP) amplitude and velocity
Measured: Through study completion, an average 2 years.
Ultrasonography
Cross-sectional area (CSA) and shear-wave velocity (SV) of:
- median nerve at wrist, forearm, elbow and upper arm
- ulnar nerve at wrist, forearm, elbow and upper arm
- radial nerve at elbow and upper arm
- vagus nerve
- brachial plexus (C5,6 and 7)
- fibular nerve at capitulum fibulae and popliteal fossa
- tibial nerve at the medial malleolus and popliteal fossa
- sciatic nerve
- sural nerve
Measured: Through study completion, an average 2 years.
Patient history
- demographic data: sex, date of birth, height, weight
- symptoms duration (months), symptoms, therapy
Measured: Through study completion, an average 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolyneuropathiesStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana, Faculty of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390527
- Sponsor's protocol ID
- USpolyneuropathy
- Status last verified
- Apr 2024
- First submitted
- 3 Jan 2024
- Last updated
- 30 Apr 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 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Ultrasound Sheer Wave Elastography for the Evaluation of Peripheral Nerve Disorders
- ClinicalTrials.gov ID
- NCT06390527
- Acronym / sponsor ID
- USpolyneuropathy
- Conditions
- Polyneuropathies
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- University of Ljubljana, Faculty of Medicine
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 30 Apr 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 main goal of this trial is to establish recommendations for clinical practice that enhance the reliability, accessibility and convenience of sheer wave elastography as a routine diagnostic test for diverse peripheral neuropathies.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with peripheral polyneuropathy recruited from the electronic database at the institute of Clinical Neurophysiologym Division of Neurology, University Medical Centre Ljubljana, Slovenia, and distributed in groups with different types of polyneuropathy.
Key inclusion criteria (2 listed)
- Age 18-80 years
- Clinical signs of particular polyneuropathy not explained by other causes
Key exclusion criteria (3 listed)
- Entrapment or compression neuropathies
- Nerve trauma
- The diagnosis of vasculitic neuropathy, neuralgic amyotrophy, diabetic radiculo-plexo-neuropathy, hereditary neuropathy with liability to pressure palsies and motor neuron disorders including monomelic amyotrophy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical examination
Time frame: Through study completion, an average 2 years.
1) Myotatic reflexes (biceps, triceps, finger flexors, patellar, Achilles, deep abdominal): 1-absent, 2-reduced or 3-present with facilitation. 1. Muscle atrophy: 1-no atrophy, 2-mild, 3-moderate or4-severe atrophy 2. Muscle strength of lower and upper limbs with Medical Research Council (MRC) scale (0-5/5): shoulder abduction, elbow flexion and extension, wrist flexion and extension, fingers flexion, extension and abduction, hip flexion, extension, abduction and adduction, knee flexion and extension, ankle dorsal flexion, plantar flexion, eversion and inversion, thumb flexion and extension. 3. Touch sensation in all dermatomes with cotton wool: 1-normal sensation, 2-mild, 3-severe or 4-absent.
Electrodiagnostic studies
Time frame: Through study completion, an average 2 years.
1. Motor nerve conduction studies in median, ulnar, radial, fibular and tibial: distal motor latency, compound muscle action potential (CMAP) amplitude, duration and area, conduction velocity. 2. Sensory nerve conduction studies in median, ulnar, superficial radial, superficial fibular and sural nerve: latency, sensory nerve action potential (SNAP) amplitude and velocity
Ultrasonography
Time frame: Through study completion, an average 2 years.
Cross-sectional area (CSA) and shear-wave velocity (SV) of: 1. median nerve at wrist, forearm, elbow and upper arm 2. ulnar nerve at wrist, forearm, elbow and upper arm 3. radial nerve at elbow and upper arm 4. vagus nerve 5. brachial plexus (C5,6 and 7) 6. fibular nerve at capitulum fibulae and popliteal fossa 7. tibial nerve at the medial malleolus and popliteal fossa 8. sciatic nerve 9. sural nerve
Patient history
Time frame: Through study completion, an average 2 years.
1. demographic data: sex, date of birth, height, weight 2. symptoms duration (months), symptoms, therapy
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 30 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Polyneuropathies, run by University Medical Centre Ljubljana.
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 2 inclusion and 3 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 30 Apr 2024. 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?
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?
Clinical examination (time frame: Through study completion, an average 2 years.). The study lists 4 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 30 Apr 2024.