ClinicalTrials.gg
Not yet recruitingNCT06390527Updated Apr 30, 2024

Ultrasonography in Diagnosis of Polyneuropathy

An observational study in Polyneuropathies, sponsored by University Medical Centre Ljubljana. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-30.

Sponsored by University Medical Centre Ljubljana · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2026, 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
120
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Polyneuropathies

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03

In context

Polyneuropathies

133 studies on the registry are indexed under Polyneuropathies; 33 are open to participants now.

This study's planned enrollment of 120 is above the median of 100 across 53 observational studies indexed under Polyneuropathies.

Browse Polyneuropathies studies →

Lead sponsor

University Medical Centre Ljubljana is the lead sponsor of 296 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-80 years
  • Clinical signs of particular polyneuropathy not explained by other causes

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
120 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Clinical examination

    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.

    Time frame: Through study completion, an average 2 years.

  2. Electrodiagnostic studies

    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

    Time frame: Through study completion, an average 2 years.

  3. Ultrasonography

    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

    Time frame: Through study completion, an average 2 years.

  4. Patient history

    1. demographic data: sex, date of birth, height, weight 2. symptoms duration (months), symptoms, therapy

    Time frame: Through study completion, an average 2 years.

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2024; primary completion for Feb 2026, 20 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 3, 2024
First posted
Apr 30, 2024
StartEst.
Jun 1, 2024
Primary completionEst.
Feb 1, 2026
CompletionEst.
Feb 1, 2027
Last update
Apr 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06390527
Collaborators
University of Ljubljana, Faculty of Medicine
Responsible party
Sponsor
First posted
Apr 30, 2024
Start date
Jun 1, 2024 (estimated)
Primary completion
Feb 1, 2026 (estimated)
Completion
Feb 1, 2027 (estimated)
Last update
Apr 30, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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