Small Fiber NeuropathyBio2TreatNCT04835779
Biometric and Biological Data for Diagnosis and Therapy of Pain Patients
An observational study of Small Fiber Neuropathy, run by RWTH Aachen University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Small Fiber Neuropathy
- How many people
- 68 participants
- Where
- 1 siteGermany
- Study dates
- 10 Oct 2020to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: SFN Patients (Group A): Patients diagnosed with Small Fibre Neuropathia Healthy Volunteers (Group B): Healthy grown-up Volunteers Patients undergoing chemotherapy (Group C): Patients with imminent initiation of neurotoxic chemotherapy in cancer with solid tumors (preferably of the gastrointestinal tract) with the side-effect of SFN development. There are no plans for follow-up recruitment in case no neuropathy develops after chemo. Healthy Volunteers PREPs (Group D): Healthy grown-up Volunteers. Four subjects (2 male, 2 female) from each of the age decades 20-29, 30-39, 40-49, 50-59, 60-69.
Who may be able to join
- Group A: Criteria 1-5 Group B: Criteria 2-5 Group C: Criteria 2-6 Group D: Criteria 2-4
- Small fiber neuropathy (after clinical examination or QST or skin biopsy findings)
- Legal age
- Written declaration of consent
- Persons who are legally competent and mentally capable of following the instructions of the staff
- Sufficient affinity for independent handling of the technology used (PainWatch incl. the corresponding apps) for daily digital pain recording
- Imminent initiation of neurotoxic chemotherapy in cancer with solid tumors (preferably of the gastrointestinal tract) There are no plans for follow-up recruitment in case no neuropathy develops after chemo.
Who cannot join
- For all Groups:
- Persons who are accommodated in an institution by order of the authorities or courts
- Persons who are in a dependent or employment relationship with the auditor
- For test persons: Exclusion, if they carry a known pain-relevant genetic variant/mutation or suffer from a chronic pain disorder analogous to migraine or chronic back pain.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Uniklinik RWTH Aachen, Klinik für Palliativmedizin
Aachen, North Rhine-Westphalia, 52074
Roman Rolke, Prof.Dr.med, +49-241-8080880, rrolke@ukaachen.de
About this study
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
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
Read the 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 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.
- Conditions
- Small Fiber Neuropathy
- Keywords
- Pain, SFN
- Medical subject headings
- Small Fiber Neuropathy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SFN Patients | Patients with diagnosed Small Fibre Neuropathy | |
| Patients undergoing chemotherapy | Patients undergoing chemotherapy and are expected to develop SFN as a result | |
| Healthy Volunteer | Healthy test person | |
| Healthy Volunteer PREPs | For the pain-evoked potentials (PREPs), 20 additional healthy control subjects are to be included. Four subjects (2 male, 2 female) from each of the age decades 20-29, 30-39, 40-49, 50-59, 60-69. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PainWatch Data
pulse rate (/min)
Measured: 12 months
PainWatch Data
number of steps
Measured: 12 months
PainWatch Data
pain perception via App (Questionnaire, pain scale 1-10)
Measured: 12 months
Weather Data tracked according to GPS Location
Temperature (°C)
Measured: 12 months
Weather Data tracked according to GPS Location
Air pressure (Pa)
Measured: 12 months
Weather Data tracked according to GPS Location
Humidity (%)
Measured: 12 months
Test result QST
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
Measured: 12 months
Test result PREP (over the same back of the foot as in QST measurement)
P1 Latency (ms)
Measured: 12 months
Test result PREP (over the same back of the foot as in QST measurement)
Peak-to-Peak (microV)
Measured: 12 months
Test result PREP (over the same back of the foot as in QST measurement)
Current intensity (mA)
Measured: 12 months
Result SF 36 Questionnaire
Result SF 36 Questionnaire (different scales per question)
Measured: 12months
Results of the Multi-Electrode Array investigations
Spontaneous activity
Measured: 12 months
Results of the Multi-Electrode Array investigations
Synchronicity
Measured: 12 months
Results of the Multi-Electrode Array investigations
Field potential properties
Measured: 12 months
Results of the Multi-Electrode Array investigations
Activity inducing stimuli
Measured: 12 months
Efficiency of reprogramming and differentiation of iPS cells
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start10 Oct 2020
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Small Fiber NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Grünenthal GmbH
- Responsible party
- Principal investigator, Prof. Dr. Roman Rolke, RWTH Aachen University
- Investigators
- Roman Rolke, Prof. Dr., Principal investigator, Universitätsklinikum Aachen, AöR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835779
- Sponsor's protocol ID
- 18-018
- Acronym
- Bio2Treat
- Status last verified
- Jan 2023
- First submitted
- 11 Feb 2021
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lacomis D. Small-fiber neuropathy. Muscle Nerve. 2002 Aug;26(2):173-88. doi: 10.1002/mus.10181.
PubMed 12210380Devigili G, Tugnoli V, Penza P, Camozzi F, Lombardi R, Melli G, Broglio L, Granieri E, Lauria G. The diagnostic criteria for small fibre neuropathy: from symptoms to neuropathology. Brain. 2008 Jul;131(Pt 7):1912-25. doi: 10.1093/brain/awn093. Epub 2008 Jun 4.
PubMed 18524793Rolke R, Rolke S, Hiddemann S, Mucke M, Cuhls H, Radbruch L, Elsner F, Peuckmann-Post V. [Update palliative pain therapy]. Internist (Berl). 2016 Oct;57(10):959-970. doi: 10.1007/s00108-016-0126-7. German.
PubMed 27631529Dworkin RH, O'Connor AB, Kent J, Mackey SC, Raja SN, Stacey BR, Levy RM, Backonja M, Baron R, Harke H, Loeser JD, Treede RD, Turk DC, Wells CD. Interventional management of neuropathic pain: NeuPSIG recommendations. Pain. 2013 Nov;154(11):2249-2261. doi: 10.1016/j.pain.2013.06.004. Epub 2013 Jun 6.
PubMed 23748119Coluzzi F, Rolke R, Mercadante S. Pain Management in Patients with Multiple Myeloma: An Update. Cancers (Basel). 2019 Dec 17;11(12):2037. doi: 10.3390/cancers11122037.
PubMed 31861097Meents JE, Bressan E, Sontag S, Foerster A, Hautvast P, Rosseler C, Hampl M, Schuler H, Goetzke R, Le TKC, Kleggetveit IP, Le Cann K, Kerth C, Rush AM, Rogers M, Kohl Z, Schmelz M, Wagner W, Jorum E, Namer B, Winner B, Zenke M, Lampert A. The role of Nav1.7 in human nociceptors: insights from human induced pluripotent stem cell-derived sensory neurons of erythromelalgia patients. Pain. 2019 Jun;160(6):1327-1341. doi: 10.1097/j.pain.0000000000001511.
PubMed 30720580Mucke M, Cuhls H, Radbruch L, Baron R, Maier C, Tolle T, Treede RD, Rolke R. [Quantitative sensory testing]. Schmerz. 2014 Dec;28(6):635-46; quiz 647-8. doi: 10.1007/s00482-014-1485-4. German.
PubMed 25403802Lefaucheur JP, Ahdab R, Ayache SS, Lefaucheur-Menard I, Rouie D, Tebbal D, Neves DO, Ciampi de Andrade D. Pain-related evoked potentials: a comparative study between electrical stimulation using a concentric planar electrode and laser stimulation using a CO2 laser. Neurophysiol Clin. 2012 Jun;42(4):199-206. doi: 10.1016/j.neucli.2011.12.003. Epub 2012 Jan 20.
PubMed 22632868Hansen N, Obermann M, Uceyler N, Zeller D, Mueller D, Yoon MS, Reiners K, Sommer C, Katsarava Z. [Clinical application of pain-related evoked potentials]. Schmerz. 2012 Feb;26(1):8-15. doi: 10.1007/s00482-011-1117-1. German.
PubMed 22134376Jenkinson C, Coulter A, Wright L. Short form 36 (SF36) health survey questionnaire: normative data for adults of working age. BMJ. 1993 May 29;306(6890):1437-40. doi: 10.1136/bmj.306.6890.1437.
PubMed 8518639Lee J, Mawla I, Kim J, Loggia ML, Ortiz A, Jung C, Chan ST, Gerber J, Schmithorst VJ, Edwards RR, Wasan AD, Berna C, Kong J, Kaptchuk TJ, Gollub RL, Rosen BR, Napadow V. Machine learning-based prediction of clinical pain using multimodal neuroimaging and autonomic metrics. Pain. 2019 Mar;160(3):550-560. doi: 10.1097/j.pain.0000000000001417.
PubMed 30540621
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04835779
- Acronym / sponsor ID
- Bio2Treat / 18-018
- Conditions
- Small Fiber Neuropathy
- Keywords
- Pain, SFN
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Grünenthal GmbH
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SFN Patients | – | –Patients with diagnosed Small Fibre Neuropathy |
| Patients undergoing chemotherapy | – | –Patients undergoing chemotherapy and are expected to develop SFN as a result |
| Healthy Volunteer | – | –Healthy test person |
| Healthy Volunteer PREPs | – | –For the pain-evoked potentials (PREPs), 20 additional healthy control subjects are to be included. Four subjects (2 male, 2 female) from each of the age decades 20-29, 30-39, 40-49, 50-59, 60-69. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- SFN Patients (Group A): Patients diagnosed with Small Fibre Neuropathia Healthy Volunteers (Group B): Healthy grown-up Volunteers Patients undergoing chemotherapy (Group C): Patients with imminent initiation of neurotoxic chemotherapy in cancer with solid tumors (preferably of the gastrointestinal tract) with the side-effect of SFN development. There are no plans for follow-up recruitment in case no neuropathy develops after chemo. Healthy Volunteers PREPs (Group D): Healthy grown-up Volunteers. Four subjects (2 male, 2 female) from each of the age decades 20-29, 30-39, 40-49, 50-59, 60-69.
Key inclusion criteria (7 listed)
- Group A: Criteria 1-5 Group B: Criteria 2-5 Group C: Criteria 2-6 Group D: Criteria 2-4
- Small fiber neuropathy (after clinical examination or QST or skin biopsy findings)
- Legal age
- Written declaration of consent
- Persons who are legally competent and mentally capable of following the instructions of the staff
Key exclusion criteria (4 listed)
- Persons who are accommodated in an institution by order of the authorities or courts
- Persons who are in a dependent or employment relationship with the auditor
- For test persons: Exclusion, if they carry a known pain-relevant genetic variant/mutation or suffer from a chronic pain disorder analogous to migraine or chronic back pain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Background: PubMed 12210380Lacomis D. Small-fiber neuropathy. Muscle Nerve. 2002 Aug;26(2):173-88. doi: 10.1002/mus.10181.
- Background: PubMed 18524793Devigili G, Tugnoli V, Penza P, Camozzi F, Lombardi R, Melli G, Broglio L, Granieri E, Lauria G. The diagnostic criteria for small fibre neuropathy: from symptoms to neuropathology. Brain. 2008 Jul;131(Pt 7):1912-25. doi: 10.1093/brain/awn093. Epub 2008 Jun 4.
- Background: PubMed 27631529Rolke R, Rolke S, Hiddemann S, Mucke M, Cuhls H, Radbruch L, Elsner F, Peuckmann-Post V. [Update palliative pain therapy]. Internist (Berl). 2016 Oct;57(10):959-970. doi: 10.1007/s00108-016-0126-7. German.
- Background: PubMed 23748119Dworkin RH, O'Connor AB, Kent J, Mackey SC, Raja SN, Stacey BR, Levy RM, Backonja M, Baron R, Harke H, Loeser JD, Treede RD, Turk DC, Wells CD. Interventional management of neuropathic pain: NeuPSIG recommendations. Pain. 2013 Nov;154(11):2249-2261. doi: 10.1016/j.pain.2013.06.004. Epub 2013 Jun 6.
- Background: PubMed 31861097Coluzzi F, Rolke R, Mercadante S. Pain Management in Patients with Multiple Myeloma: An Update. Cancers (Basel). 2019 Dec 17;11(12):2037. doi: 10.3390/cancers11122037.
- Background: PubMed 30720580Meents JE, Bressan E, Sontag S, Foerster A, Hautvast P, Rosseler C, Hampl M, Schuler H, Goetzke R, Le TKC, Kleggetveit IP, Le Cann K, Kerth C, Rush AM, Rogers M, Kohl Z, Schmelz M, Wagner W, Jorum E, Namer B, Winner B, Zenke M, Lampert A. The role of Nav1.7 in human nociceptors: insights from human induced pluripotent stem cell-derived sensory neurons of erythromelalgia patients. Pain. 2019 Jun;160(6):1327-1341. doi: 10.1097/j.pain.0000000000001511.
- Background: PubMed 25403802Mucke M, Cuhls H, Radbruch L, Baron R, Maier C, Tolle T, Treede RD, Rolke R. [Quantitative sensory testing]. Schmerz. 2014 Dec;28(6):635-46; quiz 647-8. doi: 10.1007/s00482-014-1485-4. German.
- Background: PubMed 22632868Lefaucheur JP, Ahdab R, Ayache SS, Lefaucheur-Menard I, Rouie D, Tebbal D, Neves DO, Ciampi de Andrade D. Pain-related evoked potentials: a comparative study between electrical stimulation using a concentric planar electrode and laser stimulation using a CO2 laser. Neurophysiol Clin. 2012 Jun;42(4):199-206. doi: 10.1016/j.neucli.2011.12.003. Epub 2012 Jan 20.
- Background: PubMed 22134376Hansen N, Obermann M, Uceyler N, Zeller D, Mueller D, Yoon MS, Reiners K, Sommer C, Katsarava Z. [Clinical application of pain-related evoked potentials]. Schmerz. 2012 Feb;26(1):8-15. doi: 10.1007/s00482-011-1117-1. German.
- Background: PubMed 8518639Jenkinson C, Coulter A, Wright L. Short form 36 (SF36) health survey questionnaire: normative data for adults of working age. BMJ. 1993 May 29;306(6890):1437-40. doi: 10.1136/bmj.306.6890.1437.
- Background: PubMed 30540621Lee J, Mawla I, Kim J, Loggia ML, Ortiz A, Jung C, Chan ST, Gerber J, Schmithorst VJ, Edwards RR, Wasan AD, Berna C, Kong J, Kaptchuk TJ, Gollub RL, Rosen BR, Napadow V. Machine learning-based prediction of clinical pain using multimodal neuroimaging and autonomic metrics. Pain. 2019 Mar;160(3):550-560. doi: 10.1097/j.pain.0000000000001417.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Rolke, Prof. Dr. principal investigator
Universitätsklinikum Aachen, AöR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Fiber Neuropathy, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roman Rolke, Prof. Dr. (+49 241 8080880, rrolke@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PainWatch Data (time frame: 12 months). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04835779, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.