DOLORiskWP51: Peripheral Physiological Measures as Determinants of Pain Risk

Sponsor

Neuroscience Technologies SLP, Barcelona (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02985294

Collaborator

University of Oxford (Other), Institut National de la Santé Et de la Recherche Médicale, France (Other), University of Aarhus (Other), University of Dundee (Other)

200

Enrollment

Location

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates peripheral nervous system function using Multiple Excitability Measures (MEM) to obtain "electrophysiological pain phenotypes"

Condition or Disease	Intervention/Treatment	Phase
Polyneuropathies Peripheral Nerve Injuries Peripheral Nervous System Diseases Chemotherapy Effects Neuralgia	Other: Multiple Excitability Measures of peripheral nerves

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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

DOLORisk: Understanding Risk Factors and Determinants for Neuropathic Pain - Peripheral Physiological Measures as Determinants of Pain Risk

Study Start Date :

Apr 1, 2016

Anticipated Primary Completion Date :

Mar 1, 2019

Anticipated Study Completion Date :

Apr 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Cross-sectional cohort Multiple Excitability Measures of peripheral nerves on patients with chronic peripheral neuropathic pain	Other: Multiple Excitability Measures of peripheral nerves 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 Other Names: Assessment of sensory phenotype by QST (quantitative sensory testing) Questionnaires
Longitudinal cohort Multiple Excitability Measures of peripheral nerves on painless patients before and after potential chronic neuropathic pain-inducing interventions (chemotherapy, surgery)	Other: Multiple Excitability Measures of peripheral nerves 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 Other Names: Assessment of sensory phenotype by QST (quantitative sensory testing) Questionnaires

Arm

Intervention/Treatment

Cross-sectional cohort

Multiple Excitability Measures of peripheral nerves on patients with chronic peripheral neuropathic pain

Other: Multiple Excitability Measures of peripheral nerves

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

Other Names:

Assessment of sensory phenotype by QST (quantitative sensory testing)

Questionnaires

Longitudinal cohort

Multiple Excitability Measures of peripheral nerves on painless patients before and after potential chronic neuropathic pain-inducing interventions (chemotherapy, surgery)

Other: Multiple Excitability Measures of peripheral nerves

Other Names:

Assessment of sensory phenotype by QST (quantitative sensory testing)

Questionnaires

Outcome Measures

Primary Outcome Measures

Electrophysiological pain phenotypes using MEM. Pain biomarker [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 [Single assessment at baseline, before any procedure (surgery/chemotherapy)]
Predict development of neuropathic pain in susceptible patients