Clinical Trials Logo

Clinical Trial Summary

In order to meet the challenge of an unambiguous diagnosis and effective therapy of SFN or the prognosis of susceptibility to the development of SFN, this project aims to create a data basis on which software will be developed during the project. This software should later be able to combine (integrate) quantifiable biometric data collected from the patient (both objectively measured and patient reported parameters) with the results of biological analyses of the patient's own nerve cells from stem cells. We expect that the patient-specific combination and correlation of biometric and biological data can lead to a significant improvement in the diagnosis, prognosis and therapy of chronic pain. The initial data collection required for the development of such a software (Bio2Integrate) will be carried out in three different project parts: Bio2Watch, Bio2Patient and Bio2Cell


Clinical Trial Description

Bio2Watch: In this clinical project part biometric patient data of 24 SFN patients, 3 cancer patients and 21 subjects (control group) will be collected for a period of one year using a PainWatch. The term PainWatch includes an Apple Watch 5 with iPhone 8 and installed app for pain recording. With the aid of the PainWatch, the personal pain sensation in everyday life is documented and personal data such as the pulse rate and the daily number of steps, as well as environmental data, such as the prevailing air pressure, humidity and temperature are recorded. The aim is to use these data as a basis for initial indications of pain-inducing stimuli or combinations of stimuli. Bio2Patient: In this clinical project part clinically quantifiable tests are carried out, such as quantitative sensory testing (QST), which examines subjective thermal and mechanical sensory perception and pain thresholds. The goal is to determine a specific pain phenotype. In addition, pain evoked potentials (PREPs) are performed to draw conclusions about the function of thin nerve fibers (pain fibers), including projection to the brain. Supplementary SF-36 pain questionnaires are completed to assess the quality of life.For the pain-evoked potentials (PREPs), a total of 20 additional healthy control subjects are to be included (control group D). Four subjects (2 male, 2 female) from each of the age decades 20-29, 30-39, 40-49, 50-59, 60-69 will be included. Bio2Cell: In the cell-based project part induced pluripotent stem cells (iPS cells) are produced from blood cells of SFN patients, cancer patients and volunteers. These cells will be differentiated into sensory neurons that are relevant in pain processing, so-called nociceptors. Since these nociceptors are derived from the individual patient, they carry the individual genetic characteristics of the patient. These neurons are then analyzed by multi-electrode arrays (MEA). With this method environmental influences such as temperature and air pressure or drugs on the pathophysiology of the patient's are investigated. The main goal is to simulate the conditions, which lead to pain sensation in the context of Bio2Watch and Bio2Patient. Bio2Integrate: The results from Bio2Watch, Bio2Patient and Bio2Cell will then flow into the software to be developed during the project. Thus, in addition to the identification of stimuli that stimulate pain as well as a genetic correlation to certain markers will be possible. In addition, the targeted modification of the cellular properties of the patient's own sensory neurons through the application of the chemotherapeutic agent can be investigated. To this end, measurements will be made on the cells before and after the application of the substance and compare them with each other. This is the basis for components of the "machine learning " of the Bio2Integrate software.The results of the clinical subprojects are thus an essential component of Bio2Integrate. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04835779
Study type Observational
Source RWTH Aachen University
Contact Roman Rolke, Prof. Dr.
Phone +49 241 8080880
Email rrolke@ukaachen.de
Status Recruiting
Phase
Start date October 10, 2020
Completion date October 2023

See also
  Status Clinical Trial Phase
Completed NCT02537951 - Autofluorescent Flavoprotein Imaging of Intraepidermal Nerve Fibers: a Pilot Study N/A
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
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
Active, not recruiting NCT05993871 - Diabetic Small Fiber Neuropathy: Clinical, Electrophysiological and Neurosonographic Study