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NCT Number: NCT06390527

Ultrasonography in Diagnosis of Polyneuropathy

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

Primary outcomes

  1. Clinical examination

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

    • 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.
  2. Electrodiagnostic studies

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

    • 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
  3. Ultrasonography

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

    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
  4. Patient history

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

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

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Collaborators

  • University of Ljubljana, Faculty of Medicine

Registry information

Official study title

Optimization of Ultrasound Sheer Wave Elastography for the Evaluation of Peripheral Nerve Disorders

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 30, 2024
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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