NCT04621747

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

November 23, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 2, 2021

Status Verified

December 1, 2021

Enrollment Period

1 year

First QC Date

November 2, 2020

Last Update Submit

December 1, 2021

Conditions

Healthy

Keywords

NeurophysiologyPsychophysicsSensory thresholdsNeuronsPain, neuropathic

Outcome Measures

Primary Outcomes (2)

  • 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).

    Day 1

  • 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).

    Day 8

Secondary Outcomes (1)

  • Muscular aversive response.

    Day 1, Day 8

Study Arms (1)

Study group

EXPERIMENTAL

healthy volunteers aged 18-35, balanced sex ratio, all of them undergoing the same battery of psychophysical explorations.

Other: Battery of neurophysiological explorations

Interventions

Battery of neurophysiological explorationsOTHER

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.

Study group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Ability to answer French questionnaires.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Clermont Ferrand

Clermont-Ferrand, Auvergne, 63000, France

RECRUITING

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Lise Laclautre

CONTACT

0473754963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 9, 2020

Study Start

November 23, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

December 2, 2021

Record last verified: 2021-12

Locations

FR(1)