Peripheral Physiological Measures as Determinants of Pain Risk (DOLORiskWP51)

August 21, 2018 updated by: Neuroscience Technologies SLP, Barcelona

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"

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Using MEM for peripheral sensory and motor axons we want to identify a set of excitability measures that:

  1. 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.
  2. Predict development of neuropathic pain in susceptible patients (longitudinal study). Neuropathic Pain Predictor for patients:

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 vincristine

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08028
        • Recruiting
        • Neuroscience technologies
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Chronic peripheral neuropathic pain
  • Painless Patient with risk to develop neuropathic pain (post-surgery, chemotherapy-induced)

Exclusion Criteria:

  • Minors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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:
  • Questionnaires
  • Assessment of sensory phenotype by QST (quantitative sensory testing)
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:
  • Questionnaires
  • Assessment of sensory phenotype by QST (quantitative sensory testing)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Single assessment (cross sectional study) at the first and only visit
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
Single assessment at baseline, before any procedure (surgery/chemotherapy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuroscience Technologies SLP, Barcelona

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

April 1, 2020

Study Registration Dates

First Submitted

November 28, 2016

First Submitted That Met QC Criteria

December 2, 2016

First Posted (Estimate)

December 7, 2016

Study Record Updates

Last Update Posted (Actual)

August 23, 2018

Last Update Submitted That Met QC Criteria

August 21, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neuroscience Technologies

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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