CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
AFI microscope +2 moredevice
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02537951
NCT02537951N/ACompleted

Autofluorescent Flavoprotein Imaging of Intraepidermal Nerve Fibers: a Pilot Study

Erasmus Medical Center·interventional·Posted Sep 2, 2015·Updated Jun 11, 2019

In Brief

A clinical study evaluating AFI microscope, negative control 1: lidocaine/prilocaine, and 1 other intervention for Small Fiber Neuropathy. Completed, enrolled 10 participants across 1 site.

Detailed Summary

Small fiber neuropathy (SFN) is a common disorder, which has a profound negative impact on quality of life because of severe neuropathic pain. To reliably establish a diagnosis of SFN is challenging, since neurological examination and nerve conduction studies are often normal. Autofluorescent flavoprotein imaging (AFI) is an optical method through which neuronal activity in the termination area of small nerve fibers in the spinal cord can be quantified. Since the epidermis also contains a high density of small nerve terminals and since the number of intraepidermal nerve fibers is greatly reduced in patients with SFN, our hypothesis is that AFI intensity is reduced in patients with SFN. To support this hypothesis, a pilot study is required in which the investigators first need to confirm the precision of AFI in the epidermis of the third finger of 10 healthy volunteers. Secondly, lidocaine/prilocaine cream will be used as a negative control. Finally, the AFI signal will be measured after application of a 8% capsaicin patch, through which (temporarily) a selective reduction of small nerve fibers can be induced, mimicking SFN. Using this experimental design, the investigators will be able to test the reliability and validity of AFI for capsaicin-induced small nerve fiber degeneration. This would be a significant step in developing an objective, rapid and non-invasive diagnostic tool to diagnose patients with SFN, which may also be utilized as a biomarker in studies that assess the efficacy of novel treatments for SFN.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2, 2015
Enrollment StartSep 1, 2015
Primary CompletionJul 1, 2016
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.8 years ago

Interventions

AFI microscopedevice

measurement of AFI intensities following increasing nociceptive stimulus intensities

negative control 1: lidocaine/prilocainedevice

measurement of AFI intensities following lidocaine/prilocaine cream

negative control 2: 8% capsaicindevice

measurement of AFI intensities following 8% capsaicin patch