Ignite Creation Date:
2024-05-06 @ 6:23 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05645874
Status:
RECRUITING
Last Update Posted:
2022-12-12
First Post:
2022-11-30
Brief Title:
Reference Values of Intraepidermal Nerve Fiber Density in Children and Small Fiber Neuropathy in Neurometabolic and Neurodevelopmental Disorders in Children
Sponsor:
Heinrich-Heine University Duesseldorf
Organization:
Heinrich-Heine University Duesseldorf
Study Overview
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 -
Status:
RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SFN_children
Brief Summary:
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 Parkinsons 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-1556 | OTHER | Ethical review board - Medical faculty Heinrich-Heine University University Hospital Düsseldorf | None |