Small Fiber Neuropathy Clinical Trial
Official title:
Autofluorescent Flavoprotein Imaging of Intraepidermal Nerve Fibers: a Pilot Study
Verified date | February 2019 |
Source | Erasmus Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | September 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - healthy volunteers Exclusion Criteria: - younger than 18 years - pre-existing neuropathy - previous allergic reaction to local anaesthetics |
Country | Name | City | State |
---|---|---|---|
Netherlands | Dept. Neurology, Erasmus MC | Rotterdam |
Lead Sponsor | Collaborator |
---|---|
Erasmus Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01911975 -
Safety and Tolerability of Lacosamide in Patients With Gain-of-function Nav1.7 Mutations Related Small Fiber Neuropathy
|
Phase 3 | |
Completed |
NCT03304522 -
A Study to Evaluate the Efficacy and Safety of VX-150 in Treating Subjects With Pain Caused by Small Fiber Neuropathy
|
Phase 2 | |
Recruiting |
NCT04310644 -
Autonomic Small Fiber Neuropathy and Ehlers Danlos Syndromes - Prospective Study and Registry
|
||
Completed |
NCT03912220 -
Evaluation of Nicotinamide Riboside in Prevention of Small Fiber Axon Degeneration and Promotion of Nerve Regeneration
|
Phase 2 | |
Completed |
NCT03401073 -
IVIg for Small Fiber Neuropathy With Autoantibodies TS-HDS and FGFR3
|
Phase 2 | |
Recruiting |
NCT03889080 -
fMRI-study in Patients With Small Fiber Neuropathy
|
||
Completed |
NCT03447756 -
Titration Study of ABX-1431
|
Phase 1 | |
Recruiting |
NCT04835779 -
Biometric and Biological Data for Diagnosis and Therapy of Pain Patients
|
||
Suspended |
NCT04611048 -
Establishing Normative Values for Thermal Detection and Pain Threshold Established by the Psi Method
|
N/A | |
Not yet recruiting |
NCT04170205 -
Causes Associated With Small Fiber Neuropathy (SFN).
|
||
Recruiting |
NCT05389566 -
Diabetes, Falls, and Fractures
|
||
Terminated |
NCT03339336 -
Efficacy and Safety Study of BIIB074 in Participants With Small Fiber Neuropathy
|
Phase 2 | |
Recruiting |
NCT05798949 -
Chronic Pain Rehabilitation in Patients With Small Fiber Neuropathy
|
N/A | |
Enrolling by invitation |
NCT05921097 -
Comparison of Histamine and Local Heating for Evoking the Axon-reflex Flare Response in Diabetes
|
||
Completed |
NCT02637700 -
Intravenous Immunoglobulin Therapy for Small Fiber Neuropathy
|
Phase 2 | |
Recruiting |
NCT04759443 -
Detection of Small Fiber Neuropathy Using Skin Properties
|
||
Terminated |
NCT02905396 -
Spinal Cord Stimulation in Small Fibre Neuropathy
|
N/A | |
Completed |
NCT05380804 -
Cutaneous Silent Period Assessment in Primary Sjögren's Syndrome
|
||
Recruiting |
NCT03509064 -
Medico-economic and Quality of Life Impact of Sjogren-associated Small Fiber Neuropathy
|
||
Completed |
NCT05993871 -
Diabetic Small Fiber Neuropathy: Clinical, Electrophysiological and Neurosonographic Study
|