PolyneuropathiesDOLORiskWP51NCT02985294
Peripheral Physiological Measures as Determinants of Pain Risk
An observational study of Polyneuropathies and Peripheral Nerve Injuries, run by Neuroscience Technologies SLP, Barcelona at 1 site in Spain.
Trial summary
This study evaluates peripheral nervous system function using Multiple Excitability Measures (MEM) to obtain "electrophysiological pain phenotypes" Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyneuropathies, Peripheral Nerve Injuries, Peripheral Nervous System Diseases
- What is being tested?
- Multiple Excitability Measures of peripheral nerves
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2016to Apr 2020
- How long will I take part?
- 3 Years
- 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
- No healthy volunteers
- Adult, Older adult
Study population: 1. Painless patients and patients with chronic peripheral neuropathic pain 2. Susceptible patients for developing pain i. Undergoing surgical procedures associated with a relatively high risk of developing neuropathic pain such as thoracotomy and hernia repair ii. Planning to start chemotherapy with potentially neurotoxic agents such as taxol, vincristine, etc.
Who may be able to join
- Chronic peripheral neuropathic pain
- Painless Patient with risk to develop neuropathic pain (post-surgery, chemotherapy-induced)
Who cannot join
- Minors
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Neuroscience technologies
Barcelona, 08028
Romà Solà, MD, 0034 93 4020164, rsola@nsc-tec.com
About this study
Official title: DOLORisk: Understanding Risk Factors and Determinants for Neuropathic Pain - Peripheral Physiological Measures as Determinants of Pain Risk
This study evaluates peripheral nervous system function using Multiple Excitability Measures (MEM) to obtain "electrophysiological pain phenotypes"
Read the detailed description
Using MEM for peripheral sensory and motor axons we want to identify a set of excitability measures that:
- Correlate with parameters of clinical pain and of pain processing in existing pain patients (cross sectional study), with the aim to obtain an objective Pain Biomarker.
- Predict development of neuropathic pain in susceptible patients (longitudinal study). Neuropathic Pain Predictor for patients:
- Undergoing surgical procedures associated with a relatively high risk of developing neuropathic pain such as thoracotomy and hernia repair ii. Planning to start chemotherapy with potentially neurotoxic agents such as vincristine
- Conditions
- Polyneuropathies, Peripheral Nerve Injuries, Peripheral Nervous System Diseases, Chemotherapy Effects, Neuralgia
- Being tested
- Multiple Excitability Measures of peripheral nerves
- Keywords
- Neuropathic pain, Quantitative Sensory Testing, Multiple Excitability Measures, Threshold Tracking
- Medical subject headings
- Polyneuropathies, Peripheral Nerve Injuries, Peripheral Nervous System Diseases, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple Excitability Measures of peripheral nervesOther
Also called Assessment of sensory phenotype by QST (quantitative sensory testing), Questionnaires
The technique of threshold tracking can be used to obtain several measures of peripheral nerve excitability (Multiple Excitability Measures or MEM), such as refractoriness, supernormality, strength-duration time constant and 'threshold electrotonus' (i.e. the changes in threshold produced by long-lasting depolarizing or hyperpolarizing current pulses). Each of these measurements depends on membrane potential and on other biophysical properties of the axons. Many of these excitability parameters are very constant among different subjects, while other, such as the current/threshold parameters and the super/sub-excitability parameters, appear to be characteristic of an individual
| Study group | Role | What they receive |
|---|---|---|
| Cross-sectional cohort | Multiple Excitability Measures of peripheral nerves on patients with chronic peripheral neuropathic pain Receives: Other: Multiple Excitability Measures of peripheral nerves | |
| Longitudinal cohort | Multiple Excitability Measures of peripheral nerves on painless patients before and after potential chronic neuropathic pain-inducing interventions (chemotherapy, surgery) Receives: Other: Multiple Excitability Measures of peripheral nerves |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrophysiological pain phenotypes using MEM. Pain biomarker
Correlate with parameters of clinical pain and of pain processing in existing pain patients
Measured: Single assessment (cross sectional study) at the first and only visit
Electrophysiological pain phenotypes using MEM. Pain predictor
Predict development of neuropathic pain in susceptible patients
Measured: Single assessment at baseline, before any procedure (surgery/chemotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2019 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolyneuropathiesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Neuroscience Technologies SLP, Barcelona
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Oxford, Institut National de la Santé Et de la Recherche Médicale, France, University of Aarhus, University of Dundee
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985294
- Sponsor's protocol ID
- Neuroscience Technologies
- Acronym
- DOLORiskWP51
- Status last verified
- Aug 2018
- First submitted
- 28 Nov 2016
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DOLORisk: Understanding Risk Factors and Determinants for Neuropathic Pain - Peripheral Physiological Measures as Determinants of Pain Risk
- ClinicalTrials.gov ID
- NCT02985294
- Acronym / sponsor ID
- DOLORiskWP51 / Neuroscience Technologies
- Conditions
- Polyneuropathies, Peripheral Nerve Injuries, Peripheral Nervous System Diseases, Chemotherapy Effects, Neuralgia
- Keywords
- Neuropathic pain, Quantitative Sensory Testing, Multiple Excitability Measures, Threshold Tracking
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Neuroscience Technologies SLP, BarcelonaIndustry (pharma, biotech, devices)
- Collaborators
- University of Oxford, Institut National de la Santé Et de la Recherche Médicale, France, University of Aarhus, University of Dundee
- Study start
- Apr 2016
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 7 Dec 2016 (estimated)
- 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.
This study evaluates peripheral nervous system function using Multiple Excitability Measures (MEM) to obtain "electrophysiological pain phenotypes"
Detailed description
Using MEM for peripheral sensory and motor axons we want to identify a set of excitability measures that:
- Correlate with parameters of clinical pain and of pain processing in existing pain patients (cross sectional study), with the aim to obtain an objective Pain Biomarker.
- Predict development of neuropathic pain in susceptible patients (longitudinal study). Neuropathic Pain Predictor for patients:
- Undergoing surgical procedures associated with a relatively high risk of developing neuropathic pain such as thoracotomy and hernia repair ii. Planning to start chemotherapy with potentially neurotoxic agents such as vincristine
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cross-sectional cohort | – | Other: Multiple Excitability Measures of peripheral nervesMultiple Excitability Measures of peripheral nerves on patients with chronic peripheral neuropathic pain |
| Longitudinal cohort | – | Other: Multiple Excitability Measures of peripheral nervesMultiple Excitability Measures of peripheral nerves on painless patients before and after potential chronic neuropathic pain-inducing interventions (chemotherapy, surgery) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Painless patients and patients with chronic peripheral neuropathic pain 2. Susceptible patients for developing pain i. Undergoing surgical procedures associated with a relatively high risk of developing neuropathic pain such as thoracotomy and hernia repair ii. Planning to start chemotherapy with potentially neurotoxic agents such as taxol, vincristine, etc.
Key inclusion criteria (2 listed)
- Chronic peripheral neuropathic pain
- Painless Patient with risk to develop neuropathic pain (post-surgery, chemotherapy-induced)
Key exclusion criteria (1 listed)
- Minors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple Excitability Measures of peripheral nervesAlso: Assessment of sensory phenotype by QST (quantitative sensory testing), QuestionnairesThe technique of threshold tracking can be used to obtain several measures of peripheral nerve excitability (Multiple Excitability Measures or MEM), such as refractoriness, supernormality, strength-duration time constant and 'threshold electrotonus' (i.e. the changes in threshold produced by long-lasting depolarizing or hyperpolarizing current pulses). Each of these measurements depends on membrane potential and on other biophysical properties of the axons. Many of these excitability parameters are very constant among different subjects, while other, such as the current/threshold parameters and the super/sub-excitability parameters, appear to be characteristic of an individual | Other | Cross-sectional cohort, Longitudinal cohort |
Primary outcome
Electrophysiological pain phenotypes using MEM. Pain biomarker
Time frame: Single assessment (cross sectional study) at the first and only visit
Correlate with parameters of clinical pain and of pain processing in existing pain patients
Electrophysiological pain phenotypes using MEM. Pain predictor
Time frame: Single assessment at baseline, before any procedure (surgery/chemotherapy)
Predict development of neuropathic pain in susceptible patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- 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.
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 Polyneuropathies and Peripheral Nerve Injuries, run by Neuroscience Technologies SLP, Barcelona at 1 site in Spain.
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 2 inclusion and 1 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 23 Aug 2018. 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 Spain. 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 Romà Solà, MD (0034 934020164, rsola@nsc-tec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrophysiological pain phenotypes using MEM. Pain biomarker (time frame: Single assessment (cross sectional study) at the first and only visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2018.