Ultrasound-driven Stratification in CIDP

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Conditions studied: CIDP, Chronic Inflammation, Demyelinating Polyneuropathy

In brief

Chronic inflammatory demyelinating polyradiculoneuritis (CIDP) is a rare autoimmune neuropathy characterized by significant clinical and therapeutic heterogeneity. Despite the availability of effective treatments, the response to intravenous immunoglobulins remains highly variable, and there are currently no validated biomarkers that can predict this response. At the same time, high-resolution nerve ultrasound now makes it possible to identify different morphological profiles that may reflect distinct pathophysiological mechanisms. This prospective, observational, single-center study, conducted at the Nice University Hospital, aims to determine whether nerve ultrasound profiles are associated with therapeutic response, clinical severity, and various biomarkers in the blood and cerebrospinal fluid. It includes two predefined cohorts: 20 patients with newly diagnosed PIDC, enrolled before the initiation of immunomodulatory treatment (Group 1), and 10 patients with refractory PIDC and clinically significant disability despite adequate prior treatment (Group 2). The ultimate goal is to develop a stratification strategy that will enable more personalized care for patients with PIDC.

Key facts

Study ID

NCT07719153

Run by

Centre Hospitalier Universitaire de Nice

People needed

30

Starts

2026-09-01

Expected to finish

2029-09-30

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female aged 18 years or older.
• Diagnosis of CIDP according to the 2021 EAN/PNS criteria; eligible phenotypes include typical CIDP, asymmetric CIDP (MADSAM/Lewis-Sumner syndrome), and pure motor CIDP. Pure sensory CIDP is excluded.
• Ability to undergo protocol assessments, including clinical evaluation, electrophysiological studies, nerve ultrasound, and blood sampling.
• Ability to provide written informed consent.
• Affiliation with a health insurance system or equivalent.
• Group 1-specific criteria:
• Newly diagnosed CIDP.
• No previous immunomodulatory treatment for CIDP before baseline study assessment.
• Planned initiation of IVIg according to standard clinical practice.
• Group 2-specific criteria:
• Established CIDP with persistent clinically relevant disability.
• Documented inadequate, partial, transient, or absent response despite adequate prior therapy, according to the final refractory disease definition.
• Stable treatment exposure before inclusion according to the final protocol.

You may not qualify if…

• Pure sensory CIDP.
• Alternative cause of neuropathy, including hereditary, metabolic, toxic, or other acquired neuropathies judged to better explain the clinical picture.
• Motor neuron disease, myopathy, neuromuscular junction disorder, or another neurological or neuromuscular condition interfering with clinical, electrophysiological, or ultrasound interpretation.
• CIDP mimic or alternative diagnosis.
• Active infection likely to influence study assessments.
• Active malignancy or other major systemic condition likely to confound biomarker interpretation.
• Concomitant autoimmune or inflammatory disease likely to materially influence cytokine or complement measurements.
• Severe psychiatric or cognitive disorder interfering with participation.
• Participation in another interventional trial when incompatible with the present protocol.
• Inability or unwillingness to comply with study procedures.

Full record on ClinicalTrials.gov

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