Ignite Creation Date:
2024-05-06 @ 3:25 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04621747
Status:
UNKNOWN
Last Update Posted:
2021-12-02
First Post:
2020-11-02
Brief Title:
Trial Investigating the Characteristics of Knismesis - a Lever to Explore Allodynia in Neuropathic Pain
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
Trial Investigating the Characteristics of Knismesis - a Lever to Explore Allodynia in Neuropathic Pain
Status:
UNKNOWN
Status Verified Date:
2021-12
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:
TICKLE
Brief Summary:
Also known as a moving itch knismesis is a mildly annoying sensation caused by a light movement on the skin such as from a crawling insect Its underlying mechanism rely on spatial summation ie amplification of the signal due to summation of stimulated fields like it is for dynamic allodynia in neuropathic pain This physiological study aims at determining the physical factors of the cutaneous stimulation inducing knismesis as well as the effect of confounding factors The main area of exploration will be the back because of its size and the possibility to blind the participant The information collected along with animal data in surrogate models would help to better understand neuropathic pain in the future
Detailed Description:
This is a physiological proof-of-concept also aiming to validate a functional exploration model in healthy volunteers Each participant will undergo a battery if psychometric then psychophysics tests presented sequentially However most of the main study tests knismesis will be admistered in a random order crossover The primary endpoint is to characterise in the healthy human the physical determinants of the cutaneous stimulation inducing knismesis length of the pathway speed direction intensity continuity break of the contact hairiness body site or distraction by other cutaneous stimuli The secondary endpoint is to study the relationship between the individual sensitivity to spatial summation knismesis and other individual sensitivities or profiles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None