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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47157

Enrollment

265

Registered

2015-02-09

Start date

2015-04-23

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

peripheral nerve damage polyneuropathy

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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: Exclusion criteria A potential subject who meets any of the following criteria will be excluded from participation in this study: age 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).

Design outcomes

Primary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results