Trial Investigating the Characteristics of Knismesis - a Lever to Explore Allodynia in Neuropathic Pain (TICKLE)
Primary Purpose
Healthy
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Battery of neurophysiological explorations
Sponsored by
About this trial
This is an interventional basic science trial for Healthy focused on measuring Neurophysiology, Psychophysics, Sensory thresholds, Neurons, Pain, neuropathic
Eligibility Criteria
Inclusion Criteria:
- Ability to answer French questionnaires.
· BMI between 19 and 30 kg/m2 at inclusion.
Exclusion Criteria:
- Pregnancy or breastfeeding.
- Natural intolerance to tickling.
- Any cutaneous, ocular or neurological disease contraindicating the psychophysical tests.
- Any disease or medical history that could expose the subject to unacceptable risk during the study.
- Any medication intake within 7 days before testing.
- History of drug or alcohol abuse.
- Involvement in another concomitant research protocol.
- Major dorsal hairiness.
- Inability to undergo the tests.
- Legal protection.
- Concomitant involvement in another clinical research.
- Refusal to participate.
Sites / Locations
- University Hospital, Clermont FerrandRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study group
Arm Description
healthy volunteers aged 18-35, balanced sex ratio, all of them undergoing the same battery of psychophysical explorations.
Outcomes
Primary Outcome Measures
Intensity of annoying sensation
After training, the annoying sensation is expressed by the subject through a handgrip dynamometer (Biopac systems). The signal will be treated and converted into area-under-curve response (Dualé C et al., Reg Anesth Pain Med 2011; 36:110-115).
Intensity of annoying sensation
After training, the annoying sensation is expressed by the subject through a handgrip dynamometer (Biopac systems). The signal will be treated and converted into area-under-curve response (Dualé C et al., Reg Anesth Pain Med 2011; 36:110-115).
Secondary Outcome Measures
Muscular aversive response.
The muscular aversive response will be assessed by surface electromyography through paraspinal contact electrodes (Biopac systems).
Full Information
NCT ID
NCT04621747
First Posted
November 2, 2020
Last Updated
December 1, 2021
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
NEURO-DOL (UMR 1107 INSERM / UCA)
1. Study Identification
Unique Protocol Identification Number
NCT04621747
Brief Title
Trial Investigating the Characteristics of Knismesis - a Lever to Explore Allodynia in Neuropathic Pain
Acronym
TICKLE
Official Title
Trial Investigating the Characteristics of Knismesis - a Lever to Explore Allodynia in Neuropathic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 23, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
NEURO-DOL (UMR 1107 INSERM / UCA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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, i.e. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Neurophysiology, Psychophysics, Sensory thresholds, Neurons, Pain, neuropathic
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
healthy volunteers aged 18-35, balanced sex ratio, all of them undergoing the same battery of psychophysical explorations.
Intervention Type
Other
Intervention Name(s)
Battery of neurophysiological explorations
Intervention Description
Visit 1: Biometry collection: gender, age, weight, height, eye colour.
Questionnaires : the State and Trait Anxiety Inventory and the Pain Sensitivity
Threshold of unpleasant light brightness, mechanical sensitivity threshold (von Frey hair).
Training to estimate unpleasantness Under nociceptive and tickling stimuli, to use the handgrip.
Mechanical pain threshold (electronic von Frey), heat pain threshold (Medoc Pathway).
48 stimulations applied to the back skin, following a predetermined plan with 12 different pathways, imbricated with 4 different speeds of movement.
Visit 2 (1 to 8 days later) :
42 stimulations applied to the back skin, to test the effect of stimulation intensity, the side of application, continuity break of the contact, and distraction by other cutaneous stimuli. The stimuli will follow the best paradigm as identified at the previous visit.
12 stimulations applied to forearm, cheeks, lower limbs, also testing the effect of hairiness.
Primary Outcome Measure Information:
Title
Intensity of annoying sensation
Description
After training, the annoying sensation is expressed by the subject through a handgrip dynamometer (Biopac systems). The signal will be treated and converted into area-under-curve response (Dualé C et al., Reg Anesth Pain Med 2011; 36:110-115).
Time Frame
Day 1
Title
Intensity of annoying sensation
Description
After training, the annoying sensation is expressed by the subject through a handgrip dynamometer (Biopac systems). The signal will be treated and converted into area-under-curve response (Dualé C et al., Reg Anesth Pain Med 2011; 36:110-115).
Time Frame
Day 8
Secondary Outcome Measure Information:
Title
Muscular aversive response.
Description
The muscular aversive response will be assessed by surface electromyography through paraspinal contact electrodes (Biopac systems).
Time Frame
Day 1, Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Ability to answer French questionnaires.
· BMI between 19 and 30 kg/m2 at inclusion.
Exclusion Criteria:
Pregnancy or breastfeeding.
Natural intolerance to tickling.
Any cutaneous, ocular or neurological disease contraindicating the psychophysical tests.
Any disease or medical history that could expose the subject to unacceptable risk during the study.
Any medication intake within 7 days before testing.
History of drug or alcohol abuse.
Involvement in another concomitant research protocol.
Major dorsal hairiness.
Inability to undergo the tests.
Legal protection.
Concomitant involvement in another clinical research.
Refusal to participate.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Laclautre
Phone
0473754963
Email
promo_interne_drci@chu-clermontferrand.fr
Facility Information:
Facility Name
University Hospital, Clermont Ferrand
City
Clermont-Ferrand
State/Province
Auvergne
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lise laclautre
Phone
0473754963
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Christian Dualé
12. IPD Sharing Statement
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Trial Investigating the Characteristics of Knismesis - a Lever to Explore Allodynia in Neuropathic Pain
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