Ultrasonography in Diagnosis of Polyneuropathy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Polyneuropathies

• Study Type: Observational
• Enrollment (Estimated): 120

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical examination	1) 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.	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	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	Through study completion, an average 2 years.
Patient history	demographic data: sex, date of birth, height, weight; symptoms duration (months), symptoms, therapy	Through study completion, an average 2 years.

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Collaborators: University of Ljubljana, Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 3, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyneuropathies
• Other Study ID Numbers: USpolyneuropathy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No