IgM (anti-MAG) peripheral Neuropathy: from proper assessments to trial needs (IMAGiNe study).

IgM (anti-MAG) peripheral Neuropathy: from proper assessments to trial needs (IMAGiNe study). - IMAGiNe study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45839

Enrollment

100

Registered

2016-06-08

Start date

2016-08-31

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

IgM monoclonal gammopathy associated polyneuropathy nerve disorder

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - fulfilling the international criteria for the diagnosis IgM monoclonal gammopathy and peripheral neuropathy - age 18 years or older - written informed consent given by the participant

Exclusion criteria

Exclusion criteria: - having concomitant diseases possibly interfering with peripheral nerve and function, as well as physical functioning, such as diabetes, renal insufficiency, prior treatment with chemotherapy for diseases other than their IgM monoclonal gammopathy associated peripheral neuropathy, alcohol abuse (more than 5 IU/day); - having severe, active malignancy with poor prognosis, undergoing treatment aside from monoclonal gammopathy associated peripheral neuropathy; - pregnancy - use any medication that may influence peripheral nerve function.

Design outcomes

Primary

Measure	Time frame
Data collection will be based on the formats derived from the Dutch ALS and IGOS studies. The following study parameters will be of interest: weakness ((RT)- MRC sum score), sensibility ((RT)- Modified ISS), disability (MGUSP-RODS), ataxia (MICARS/SARA), quality of life (EuroQol EQ-5D Health Questionnaire), pain (Pain-Intensity Numerical Rating Scale).	—

Secondary

Measure	Time frame
-	—

Countries

Netherlands

Outcome results