Trial Investigating the Characteristics of Knismesis - a Lever to Explore Allodynia in Neuropathic Pain (TICKLE)

December 1, 2021 updated by: University Hospital, Clermont-Ferrand
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Auvergne
      • Clermont-Ferrand, Auvergne, France, 63000
        • Recruiting
        • University Hospital, Clermont Ferrand
        • Principal Investigator:
          • Christian DUALE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study group
healthy volunteers aged 18-35, balanced sex ratio, all of them undergoing the same battery of psychophysical explorations.
Other: Battery of neurophysiological explorations

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intensity of annoying sensation
Time Frame: Day 1
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
Time Frame: Day 8
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscular aversive response.
Time Frame: Day 1, Day 8
The muscular aversive response will be assessed by surface electromyography through paraspinal contact electrodes (Biopac systems).
Day 1, Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Clermont-Ferrand

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
NEURO-DOL (UMR 1107 INSERM / UCA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 23, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RBHP 2020 DUALE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings