Peripheral Physiological Measures as Determinants of Pain Risk

• Conditions: Polyneuropathies; Peripheral Nerve Injuries; Chemotherapy Effects; Neuralgia; Peripheral Nervous System Diseases
• Interventions: Other: Multiple Excitability Measures of peripheral nerves

• Registration Number: NCT02985294
• Lead Sponsor: Neuroscience Technologies SLP, Barcelona

Brief Summary

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:

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 Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-11-28
• Study First Submitted QC: 2016-12-02
• Study First Posted: 2016-12-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-21
• Last Update Posted: 2018-08-23
• Primary Completion: 2019-03
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• Minors

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cross-sectional cohort	Multiple Excitability Measures of peripheral nerves	Multiple Excitability Measures of peripheral nerves on patients with chronic peripheral neuropathic pain
Longitudinal cohort	Multiple Excitability Measures of peripheral nerves	Multiple Excitability Measures of peripheral nerves on painless patients before and after potential chronic neuropathic pain-inducing interventions (chemotherapy, surgery)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Neuroscience technologies; 🇪🇸 Barcelona, Spain