not applicable: healthy volunteers
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - competent male or female volunteers of 18 years or older, who can speak and understand the Dutch language
Exclusion criteria
Exclusion criteria: - Proven or suspected neuropathy - Nerve injury and/or neuropathy in one or both hands or legs - Abnormal neurological exam - Diabetes mellitus - Vitamin B12 deficiency - Hypothyroidism - Malignancy - Renal failure - HIV/AIDS - skin disorders at the hands or legs - (history of) chemotherapy - (history of) chronic alcohol abusis, >4IU/day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the peptidergic and non-peptidergic intra-epidermal nerve fiber density of the hand and distal leg. Reference values for intra-epidermal nerve fiber density will be stratified for age and for gender and will be provided as the 5th percentile and the mean. Intra-epidermal nerve fiber density will be expressed in fibers/mm. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome is the difference in intra-epidermal nerve fiber density between the 3 different biopsy sites of the hand. Furthermore, we will describe adverse events in case they occur. | — |
Countries
Netherlands