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EXPLORE-SFN Diagnostics: EXtensive Patient LOngitudinal data REgistry for Small Fiber Neuropathy Diagnostics

EXPLORE-SFN Diagnostics: EXtensive Patient LOngitudinal data REgistry for Small Fiber Neuropathy Diagnostics - EXPLORE-SFN Diagnostics

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON53455
Enrollment
100
Registered
2023-05-31
Start date
2024-08-27
Completion date
Unknown
Last updated
2024-11-18

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

Conditions

Small fiber neuropathy

Interventions

None listed

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Definite small fiber neuropathy (SFN): a) Subjects of 18 years and older b) Clinical symptoms and signs of SFN c) Abnormal intraepidermal nerve fiber density (IENFD) in skin biopsy of the distal leg d) Subjects must give informed consent by signing and dating an informed consent form Probable SFN: a) Subjects of 18 years and older b) Clinical symptoms and signs of SFN c) Normal IENFD in skin biopsy of the distal leg d) Abnormal quantitative sensory testing (QST) e) Subjects must give informed consent by signing and dating an informed consent form

Exclusion criteria

Exclusion criteria: a) Signs of large nerve fiber neuropathy in neurological examination (weakness, loss of vibration sense, hypo-/areflexia) b) Abnormal nerve conduction studies

Design outcomes

Primary

MeasureTime frame
The primary endpoint is an electronic web-based registry, which reflects the natural course of SFN and change over time in the diagnostics of SFN. Changes in neurological examination, nerve conduction studies, IENFD, quantitative sensory testing and their relation to SFN-related symptoms, daily functioning and QoL will be demonstrated.

Secondary

MeasureTime frame
The secondary endpoint is if and what diagnostics could ultimately be used in future trials.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)