Peripheral Physiological Measures as Determinants of Pain Risk

NCT02985294 | Unknown DMC

• 1 other identifier: Neuroscience Technologies
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Polyneuropathies; Peripheral Nerve Injuries; Peripheral Nervous System Diseases; Chemotherapy Effects; Neuralgia

Keywords

Neuropathic pain; Quantitative Sensory Testing; Multiple Excitability Measures; Threshold Tracking

Outcome Measures

Primary Outcomes (2)

• Electrophysiological pain phenotypes using MEM. Pain biomarker

  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

  Predict development of neuropathic pain in susceptible patients

  Single assessment at baseline, before any procedure (surgery/chemotherapy)

Study Arms (2)

Cross-sectional cohort

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

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)

Other: Multiple Excitability Measures of peripheral nerves

Interventions

Multiple Excitability Measures of peripheral nerves 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

Also known as: Assessment of sensory phenotype by QST (quantitative sensory testing), Questionnaires

Cross-sectional cohort; Longitudinal cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Minors

Sponsors & Collaborators

• Neuroscience Technologies SLP, Barcelona: lead
• University of Oxford: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• University of Aarhus: collaborator
• University of Dundee: collaborator

Study Sites (1)

Neuroscience technologies

Barcelona, 08028, Spain

RECRUITING

Related Links

• Official Consortium web site

Biospecimen

Retention: SAMPLES WITH DNA

blood sample

MeSH Terms

Conditions

Polyneuropathies; Peripheral Nerve Injuries; Peripheral Nervous System Diseases; Neuralgia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Romà Solà, MD

CONTACT

0034 934020164; rsola@nsc-tec.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: December 7, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: April 1, 2020
• Last Updated: August 23, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)