Peripheral Physiological Measures as Determinants of Pain Risk

NCT ID: NCT02985294

Last Updated: 2018-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2020-04-30

Brief Summary

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

Detailed Description

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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

Conditions

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Polyneuropathies Peripheral Nerve Injuries Peripheral Nervous System Diseases Chemotherapy Effects Neuralgia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cross-sectional cohort

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

Multiple Excitability Measures of peripheral nerves

Intervention Type OTHER

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

Longitudinal cohort

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

Multiple Excitability Measures of peripheral nerves

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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Assessment of sensory phenotype by QST (quantitative sensory testing) Questionnaires

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Minors
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oxford

OTHER

Sponsor Role collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role collaborator

University of Dundee

OTHER

Sponsor Role collaborator

Neuroscience Technologies SLP, Barcelona

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Neuroscience technologies

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Romà Solà, MD

Role: CONTACT

0034 934020164

Facility Contacts

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Romà Solà, MD

Role: primary

0034 93 4020164

Related Links

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http://dolorisk.eu/

Official Consortium web site

Other Identifiers

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Neuroscience Technologies

Identifier Type: -

Identifier Source: org_study_id

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