Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-03-02 @ 7:43 AM
Study NCT ID:
NCT02985294
Status:
UNKNOWN
Last Update Posted:
2018-08-23
First Post:
2016-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peripheral Physiological Measures as Determinants of Pain Risk
Sponsor:
Neuroscience Technologies SLP, Barcelona
Organization:
Study Overview
Official Title:
DOLORisk: Understanding Risk Factors and Determinants for Neuropathic Pain - Peripheral Physiological Measures as Determinants of Pain Risk
Status:
UNKNOWN
Status Verified Date:
2018-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DOLORiskWP51
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: