Ultrasonography in Diagnosis of Polyneuropathy

Not yet recruiting

• Conditions: Polyneuropathies

• Registration Number: NCT06390527
• Lead Sponsor: University Medical Centre Ljubljana

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-03
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-25
• Last Update Submitted: 2024-04-25
• Study First Posted: 2024-04-30
• Last Update Posted: 2024-04-30
• Study Start: 2024-06-01
• Primary Completion: 2026-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical examination	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.
Ultrasonography	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	Through study completion, an average 2 years.	1. demographic data: sex, date of birth, height, weight; 2. symptoms duration (months), symptoms, therapy
Electrodiagnostic studies	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