Biometric and Biological Data for Diagnosis and Therapy of Pain Patients (Bio2Treat)
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|ClinicalTrials.gov Identifier: NCT04835779|
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
|Condition or disease|
|Small Fiber Neuropathy|
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.
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 Type :||Observational|
|Estimated Enrollment :||48 participants|
|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|
|Actual Study Start Date :||October 10, 2020|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||October 2023|
Patients with diagnosed Small Fibre Neuropathy
Patients undergoing chemotherapy
Patients undergoing chemotherapy and are expected to develop SFN as a result
Healthy test person
- PainWatch Data [ Time Frame: 12 months ]pulse rate (/min)
- PainWatch Data [ Time Frame: 12 months ]number of steps
- PainWatch Data [ Time Frame: 12 months ]pain perception via App (Questionnaire, pain scale 1-10)
- Weather Data tracked according to GPS Location [ Time Frame: 12 months ]Temperature (°C)
- Weather Data tracked according to GPS Location [ Time Frame: 12 months ]Air pressure (Pa)
- Weather Data tracked according to GPS Location [ Time Frame: 12 months ]Humidity (%)
- Test result QST [ Time Frame: 12 months ]Measurement exclusively above the back of the foot that is clinically more severely affected by the SFN, in a balanced row alternately above the right or left foot; one back of the foot as test site per subject
- Test result PREP (over the same back of the foot as in QST measurement) [ Time Frame: 12 months ]P1 Latency (ms)
- Test result PREP (over the same back of the foot as in QST measurement) [ Time Frame: 12 months ]Peak-to-Peak (microV)
- Test result PREP (over the same back of the foot as in QST measurement) [ Time Frame: 12 months ]Current intensity (mA)
- Result SF 36 Questionnaire [ Time Frame: 12months ]Result SF 36 Questionnaire (different scales per question)
- Results of the Multi-Electrode Array investigations [ Time Frame: 12 months ]Spontaneous activity
- Results of the Multi-Electrode Array investigations [ Time Frame: 12 months ]Synchronicity
- Results of the Multi-Electrode Array investigations [ Time Frame: 12 months ]Field potential properties
- Results of the Multi-Electrode Array investigations [ Time Frame: 12 months ]Activity inducing stimuli
- Efficiency of reprogramming and differentiation of iPS cells [ Time Frame: 12 months ]Success of differentiation will be measured by flow cytometry at around d10 of differentiation. The percentage of p75 (CD271)-expressing cells will be meassured. The differentiation is defined as successful if more than 30% of cells express p75. Only those differentiations will be used for MEA-Recordings.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04835779
|Contact: Roman Rolke, Prof. Dr.||+49 241 firstname.lastname@example.org|
|Contact: Lampert Angelika, Prof. Dr.||+49 241 80 email@example.com|
|Uniklinik RWTH Aachen, Klinik für Palliativmedizin||Recruiting|
|Aachen, Nordrhein-Westfalen, Germany, 52074|
|Contact: Roman Rolke, Prof.Dr.med +49-241-8080880 firstname.lastname@example.org|
|Principal Investigator:||Roman Rolke, Prof. Dr.||Universitätsklinikum Aachen, AöR|