Autofluorescent Flavoprotein Imaging of Intraepidermal Nerve Fibers: a Pilot Study

NCT02537951 | Completed Results DMC

• 1 other identifier: NL49568.078.14
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Small Fiber Neuropathy

Keywords

autofluorescent flavoprotein imaging, capsaicin

Outcome Measures

Primary Outcomes (1)

• AFI-intensity After Nociceptive Stimulation

  AFI-intensity (delta F/F) at the 3rd fingertip, directly after application of grading nociceptive stimuli

  Day 1, T=0h (AFI measurements), Day 1, T=6h (AFI measurements after lidocaine/prilocaine), Day 7 (AFI measurements after capsaicin)

Study Arms (3)

AFI intensity in healthy volunteers

EXPERIMENTAL

10 healthy volunteers, on whose 3rd fingertips AFI intensity is measured through an AFI microscope

Device: AFI microscope

negative control 1: lidocaine/prilocaine

ACTIVE COMPARATOR

10 healthy volunteers, on whose 3rd fingertips AFI intensity is measured through an AFI microscope, 1hour after application of lidocaine/prilocaine creme (negative control 1)

Device: negative control 1: lidocaine/prilocaine

negative control 2: 8% capsaicin

ACTIVE COMPARATOR

-10 healthy volunteers, on whose 3rd fingertips AFI intensity is measured through an AFI microscope, 1week after application of an 8% capsaicin patch (negative control 2)

Device: negative control 2: 8% capsaicin

Interventions

AFI microscope DEVICE

measurement of AFI intensities following increasing nociceptive stimulus intensities

AFI intensity in healthy volunteers

negative control 1: lidocaine/prilocaine DEVICE

measurement of AFI intensities following lidocaine/prilocaine cream

negative control 1: lidocaine/prilocaine

negative control 2: 8% capsaicin DEVICE

measurement of AFI intensities following 8% capsaicin patch

negative control 2: 8% capsaicin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy volunteers

You may not qualify if:

• younger than 18 years
• pre-existing neuropathy
• previous allergic reaction to local anaesthetics

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Dept. Neurology, Erasmus MC

Rotterdam, 3015 CE, Netherlands

Location

MeSH Terms

Conditions

Small Fiber Neuropathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Joost L.M. Jongen
• Organization: Erasmus MC

j.jongen@erasmusmc.nl

+31107041415

Study Officials

• Joost LM Jongen, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. J.L.M. Jongen, neurologist

Model Details: subjects are first undergoing measurements of AFI intensities following increasing nociceptive stimulus intensities, consequently it is tested whether the AFI activity can be blocked by lidocaine/prilocaine and a 8% capsaicin patch, i.e. whether the AFI activity is specific for nociceptor-acitivity

Study Record Dates

• First Submitted: August 22, 2015
• First Posted: September 2, 2015
• Study Start: September 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: June 11, 2019
• Results First Posted: June 3, 2019

Record last verified: 2019-02

Locations

NL (1)