HealthyTICKLENCT04621747
Trial Investigating the Characteristics of Knismesis - a Lever to Explore Allodynia in Neuropathic Pain
A study testing Battery of neurophysiological explorations in people with Healthy, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Battery of neurophysiological explorations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 23 Nov 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to answer French questionnaires.
- BMI between 19 and 30 kg/m2 at inclusion.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital, Clermont Ferrand
Clermont-Ferrand, Auvergne, 63000
lise laclautre, 0473754963, promo_interne_drci@chu-clermontferrand.fr
Christian Dualé
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Battery of neurophysiological explorations
- Keywords
- Neurophysiology, Psychophysics, Sensory thresholds, Neurons, Pain, neuropathic
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 | Role | What they receive |
|---|---|---|
| Study group | Experimental | healthy volunteers aged 18-35, balanced sex ratio, all of them undergoing the same battery of psychophysical explorations. Receives: Other: Battery of neurophysiological explorations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Day 8
Secondary outcomes (1)
Muscular aversive response.
The muscular aversive response will be assessed by surface electromyography through paraspinal contact electrodes (Biopac systems).
Measured: Day 1, Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start23 Nov 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- NEURO-DOL (UMR 1107 INSERM / UCA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621747
- Sponsor's protocol ID
- RBHP 2020 DUALE
- Acronym
- TICKLE
- Status last verified
- Dec 2021
- First submitted
- 2 Nov 2020
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial Investigating the Characteristics of Knismesis - a Lever to Explore Allodynia in Neuropathic Pain
- ClinicalTrials.gov ID
- NCT04621747
- Acronym / sponsor ID
- TICKLE / RBHP 2020 DUALE
- Conditions
- Healthy
- Keywords
- Neurophysiology, Psychophysics, Sensory thresholds, Neurons, Pain, neuropathic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- NEURO-DOL (UMR 1107 INSERM / UCA)
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Battery of neurophysiological explorationshealthy volunteers aged 18-35, balanced sex ratio, all of them undergoing the same battery of psychophysical explorations. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Ability to answer French questionnaires.
- BMI between 19 and 30 kg/m2 at inclusion.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Battery of neurophysiological explorationsVisit 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. | Other | Study group |
Primary outcome
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).
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).
1 secondary outcome
Muscular aversive response.
Time frame: Day 1, Day 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Battery of neurophysiological explorations in people with Healthy, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (0473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of annoying sensation (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021.