High-resolution sonographic visualisation of nerve morphological alterations over time in polyneuropathies: a possible new test for treatment response and prognosis

Completed

Conditions: peripheral nerve damage
polyneuropathy
10034606

Registration Number: NL-OMON47157

Lead Sponsor: Sint Elisabeth Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 265

Inclusion Criteria

Study objective 1 and 2: 20 patients with CIAP, 20 with CIDP/MIDN and 20 with MMN who are on treatment.
Study objective 3: All newly diagnosed CIAP, CIPD and MMN patients and 70 patients with CIDP/MIDN and 60 patients with MMN who are on treatment will be included.

Exclusion Criteria

Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study: age <18 or >80 years, prior history of polyneuropathy other then CIDP, MIDN or MMN, physically unable to undergo electrodiagnostic or HRUS of the peripheral nervous system (e.g. cast, recent pelvic fracture or prosthetic operation, extensive reconstructive surgery on the extremities).

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints: sonographic neural abnormalities (nerve<br /><br>hypertrophy, fascicle enlargement and hypervascularisation), clinical findings<br /><br>(ie pattern and degree of sensory disturbance (Modified INCAT Sensory Sum<br /><br>Score) and muscle weakness (medical research council (MRC) sum-score and<br /><br>Vigorimetry), results of electrodiagnostic studies, laboratory and CSF<br /><br>analysis, treatment response in treated cases, Inflammatory Neuropathy Cause<br /><br>and Treatment (INCAT) Overall Disability Sum Score (ODSS), Rasch-built Overall<br /><br>Disability Scale (R-ODS). (the R-ODS CIDP will be used for patients with CIDP<br /><br>and MIDN, the recently developed R-ODS MMN for patients with MMN; for patients<br /><br>with CIAP the Modified Rankin Scale will be used, because at the moment no<br /><br>R-ODS is available for this type of polyneuropathy.</p><br>

Secondary Outcome Measures