Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04835779
Status:
RECRUITING
Last Update Posted:
2023-01-09
First Post:
2021-02-11
Brief Title:
Biometric and Biological Data for Diagnosis and Therapy of Pain Patients
Sponsor:
RWTH Aachen University
Organization:
RWTH Aachen University
Study Overview
Official Title:
Biometric and Biological Data for Diagnosis and Therapy of Pain Patients German Biometrische Und Biologische Daten für Die Diagnose Und Therapie Bei Schmerzpatienten
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Bio2Treat
Brief 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 patients 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
Detailed 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 lifeFor 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 patients 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 patients 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 softwareThe results of the clinical subprojects are thus an essential component of Bio2Integrate
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 lifeFor 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 patients 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 patients 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 softwareThe results of the clinical subprojects are thus an essential component of Bio2Integrate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None