Reference Values of Intraepidermal Nerve Fiber Density in Children and Small Fiber Neuropathy in Neurodevelopmental Disorders
CompletedNCT05645874
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Background: Small-Fiber-Neuropathy describes the degeneration of mildly or unmyelinated nerve fibers and causes neuropathic pain and autonomic dysfunction. Gold standard for the diagnosis is a small skin punch biopsy from the lower leg and the histological quantification of the intraepidermal nerve fiber density (IENFD). In children, the normal IENFD has not been systematically assessed and normal reference values are needed. In Parkinson´s disease, the neurodegeneration also affects the peripheral nerves and SFN is present already in the early stages. Whether neurodevelopmental disorders (NDDs) in childhood are likewise associated with SFN is largely unknown. The IENFD is age-dependent and declines with age. Aims: In this study, we are establishing the reference values for the physiological IENFD in children from 0-18 years. Moreover, we are investigating if children with NDDs have a reduced IENFD and if SFN is a clinically relevant cause of pain and autonomic dysfunction.
Study details
- Official title
- Reference Values of Intraepidermal Nerve Fiber Density in Children and Small Fiber Neuropathy in Children With Acquired and Genetic Neurodevelopmental Disorders - An Unrecognized Cause of Pain and Window Into Brain Pathology ? -
- Conditions
- Mitochondrial Diseases
- Developmental Delay Disorder
- Small Fiber Neuropathy
- Cerebral Palsy
- Interventions
- Diagnostic test: Skin biopsy
- Sponsor
- Heinrich-Heine University, Duesseldorf
- Start date
- 2022-02-01
- Primary completion
- 2024-12-31
- Sex
- All
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Germany
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
control patients Inclusion Criteria: * Elective surgical intervention from lower leg * Interest to participate in the study, informed consent * Unremarkable neurological development Exclusion Criteria: * Clinical signs of polyneuropathy, autonomic dysfunction * Skin inflammation, scar, skin disease, other known chronic diseases that can cause small fiber pathology Neurodevelopmental patients Inclusion Criteria: * Neurodevelopmental problems (developmental delay, muscular hypotonia, seizures, ataxia,...) with age of onset before the age of 18 years * Interest to participate in the study, informed consent Exclusion Criteria: * Known polyneuropathy * Skin inflammation, scar, skin disease, other known chronic diseases that can cause small fiber pathology
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05645874