Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2026-02-20 @ 6:48 PM
Study NCT ID:
NCT02402361
Status:
COMPLETED
Last Update Posted:
2021-05-20
First Post:
2015-03-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding Risk Factors and Determinants for Neuropathic Pain
Sponsor:
Rambam Health Care Campus
Organization:
Study Overview
Official Title:
Understanding Risk Factors and Determinants for Neuropathic Pain
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
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:
Neuropathic
Brief Summary:
Understanding risk factors and determinants for neuropathic pain.
Detailed Description:
Neuropathic pain (NP) is common (population prevalence of 7-8%) and will present a rising health burden in the future. NP arises as a consequence of a disease or lesion in the somatosensory nervous system. NP results in significant morbidity, reduces quality of life and has a major deleterious impact on health in aging. However, not everyone with such a lesion develops significant neuropathic pain, and those who do develop it include a wide range of severity, impact and outcomes, and an unpredictable response to evidence-based treatment. The reason why some subjects develop neuropathic pain and others do not following the same injury is not known. Genetic variants are increasingly recognized as being important in the development of neuropathic pain. There are a number of Mendelian primary neuropathic pain disorders which act as exemplars of high impact gene variants which have in a number of cases been shown to alter primary afferent excitability. In addition genetic factors are also likely to be important as risk factors in more common acquired (or secondary) neuropathic pain disorders. So, identifying these risk factors will have a significant impact on health both in identifying vulnerable patients and potential for developing new treatment modalities. The proposed study is a part of multicenter international project under Horizons 2020 program of the European Union. Our aim is to understand pain pathophysiology in terms of risk factors and protective mechanisms ranging from molecular pathways to societal impacts. The desired impact is to provide a firm platform to improve diagnosis and stratify patients according to risk profile, employ preventive strategies and ultimately develop novel therapeutics.
Specific objectives for the study at large will be to: 1) Identify the influence of demographic, environmental/societal and clinical factors on the risk of developing and maintenance of NP. 2) To apply modern genomics to validate (using a targeted approach) and find novel (using genome wide association) genetic risk factors for NP. 3) To determine if patient stratification using physiological (sensory profile, endogenous analgesic mechanisms and nerve excitability) and psychological factors can predict NP risk and progression. 4) Development of a risk model/algorithm for (severe) NP, combining measurable genetic and environmental factors. The desired impact is to provide a firm platform to improve diagnosis and stratify patients according to risk profile, employ preventive strategies and ultimately develop novel therapeutics.
Specific objectives for the study at large will be to: 1) Identify the influence of demographic, environmental/societal and clinical factors on the risk of developing and maintenance of NP. 2) To apply modern genomics to validate (using a targeted approach) and find novel (using genome wide association) genetic risk factors for NP. 3) To determine if patient stratification using physiological (sensory profile, endogenous analgesic mechanisms and nerve excitability) and psychological factors can predict NP risk and progression. 4) Development of a risk model/algorithm for (severe) NP, combining measurable genetic and environmental factors. The desired impact is to provide a firm platform to improve diagnosis and stratify patients according to risk profile, employ preventive strategies and ultimately develop novel therapeutics.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: