Cerebral Palsy Clinical Trial
— SFN_childrenOfficial 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 ? -
Verified date | November 2022 |
Source | Heinrich-Heine University, Duesseldorf |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 SNF is a clinically relevant cause of pain and autonomic dysfunction.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | December 30, 2024 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 0 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Düsseldord, Department of General Pediatrics, Neonatology and Pediatric Cardiology | Düsseldorf |
Lead Sponsor | Collaborator |
---|---|
Heinrich-Heine University, Duesseldorf |
Germany,
Lauria G, Bakkers M, Schmitz C, Lombardi R, Penza P, Devigili G, Smith AG, Hsieh ST, Mellgren SI, Umapathi T, Ziegler D, Faber CG, Merkies IS. Intraepidermal nerve fiber density at the distal leg: a worldwide normative reference study. J Peripher Nerv Syst. 2010 Sep;15(3):202-7. doi: 10.1111/j.1529-8027.2010.00271.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraepidermal nerve fiber density | 2 years | ||
Secondary | Pathological protein deposits, morphological alterations of cell organells | 2 years |
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