Ultrasonography in Diagnosis of Polyneuropathy

NCT06390527 | Not Yet Recruiting

• 1 other identifier: USpolyneuropathy
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Polyneuropathies

Outcome Measures

Primary Outcomes (4)

• 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.

  Through study completion, an average 2 years.

• 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

  Through study completion, an average 2 years.

• 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

  Through study completion, an average 2 years.

• Patient history

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

  Through study completion, an average 2 years.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• University of Ljubljana, Faculty of Medicine: collaborator

MeSH Terms

Conditions

Polyneuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: April 30, 2024
• Study Start: June 1, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 30, 2024

Record last verified: 2024-04