Skip to content

Peripheral neuropathy in MLD patients: possible pathomechanisms, dynamic biomarkers and clinical relevance

Peripheral neuropathy in MLD patients: possible pathomechanisms, dynamic biomarkers and clinical relevance - Neuropathy in MLD

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48491
Enrollment
40
Registered
2019-07-26
Start date
2019-12-18
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

hereditary white matter disorder metachromatic leukodystrophy

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Diagnosis of MLD confirmed by demonstrating a deficiency of ASA activity in leukocytes, increased urinary sulfatide levels and/or pathogenic ARSA mutations.

Exclusion criteria

Exclusion criteria: No informed consent (IC) given by the participant or given by parents/legal representative if necessary

Design outcomes

Primary

MeasureTime frame
The primary study parameters will be the: Total pmTNS score (between 0 * 32) and nerve conduction velocities (m/s) of the radial nerve, ulnar nerve, tibial nerve and common peroneal nerve in MLD patients at three different time points, and the changes in the total pmTNS score and NCV over time. Correlation between levels of different sulfatide species and biomarkers (protein level) in CSF and blood and the severity of peripheral neuropathy in MLD patients at three different time points and over time. Changes in size, vascularity and echogenicity of the radial nerve, ulnar nerve, tibial nerve and common peroneal nerve in MLD patients over time.

Secondary

MeasureTime frame
The secondary study parameters will be the: Calculated differences in total pmTNS scores and nerve conduction velocities at baseline between different MLD patient subgroups. Absolute levels of sulfatide and elevated or lowered biomarkers in CSF and blood in MLD patients at three different time points and the calculated differences with these levels in CSF and blood in healthy controls. Correlation between size, vascularity and echogenicity of the radial nerve, ulnar nerve, tibial nerve and common peroneal nerve and different stages of the disease.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)