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Testing Protocol to Efficiently Induce Itch

Nerve Excitability Testing Protocol to Efficiently Induce Itch

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05195177
Acronym
ELIT
Enrollment
20
Registered
2022-01-18
Start date
2021-11-25
Completion date
2023-12-20
Last updated
2023-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Itch

Brief summary

This subproject aims to evaluate a new nerve excitability protocol to induce itch in healthy controls by electrical stimulation. Itch has many similarities with pain, and the nerve fibers that mediate the two sensations probably have the same morphological and excitability properties. The method used in this project will be the same as our research group uses for studying nociceptor fibers (PTT technique), but the focus is on the itch sensation. Since the itch fibers also terminate in the epidermis, our PTT technique should also be able to activate itch fibers, similar to pain fibers. If itch could be effectively induced by electrical stimulation, this would generate a valuable tool for studying itch in healthy controls. The sub-project takes place in 2 sessions (2 hours each).

Interventions

DRUGAnti-histamine cream 1 hour

At the start of session 1, one area of the middle forearms of the participant will be located (4x4cm). On the area, anti-histamine cream will be applied for approximately 1 hour.

DRUGLocal anesthetic cream 1 hour

At the start of session 2, one area of the middle forearms of the participant will be located (4x4cm). On the area, local anesthetic cream (2.5% lidocain/2.5 prilocaine) will be applied for approximately 1 hour.

Sponsors

Aalborg University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy men and women in the age 18-80 years who speak and understand

Exclusion criteria

* Pregnancy or breast feeding * Drug addiction defined as the use of cannabis, opioids or other drugs * Previous and present neurologic, musculoskeletal or mental illnesses (e.g., epilepsy, neuropathy, fibromyalgia and depression) * Skin diseases * Past history of conditions possibly leading to neuropathy * Inability to cooperate * Current use of medications that may affect the study, e.g., analgesics * Previous traumatic experience of an electrical accident * Consumption of alcohol or painkillers within the last 24 hours * Participation in other pain studies throughout the study period * Patients with cardiac diseases (e.g., pacemaker).

Design outcomes

Primary

MeasureTime frameDescription
Perception threshold for pulse shape 1This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.The perception threshold will be estimated for the electrical stimuli with pulse shape 1. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Perception threshold for pulse shape 2This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.The perception threshold will be estimated for the electrical stimuli with pulse shape 2. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Perception threshold for pulse shape 3This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.The perception threshold will be estimated for the electrical stimuli with pulse shape 3. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Perception threshold for pulse shape 4This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.The perception threshold will be estimated for the electrical stimuli with pulse shape 4. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Perception threshold for pulse shape 1 when antihistamine cream has been appliedThis outcome measurement will be estimated during session one. The outcome measure takes approximately 5 minutes to estimate.The perception threshold will be estimated for the electrical stimuli with pulse shape 1 when anti-histamine cream has been applied for approximately an hour. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Perception threshold for pulse shape 2 when anti-histamine cream has been appliedThis outcome measurement will be estimated during session one. The outcome measure takes approximately 5 minutes to estimate.The perception threshold will be estimated for the electrical stimuli with pulse shape 2 when anti-histamine cream has been applied for approximately an hour. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Perception threshold for pulse shape 3 when anti-histamine cream has been appliedThis outcome measurement will be estimated during session one. The outcome measure takes approximately 5 minutes to estimate.The perception threshold will be estimated for the electrical stimuli with pulse shape 3 when anti-histamine cream has been applied for approximately an hour. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Perception threshold for pulse shape 4 when anti-histamine cream has been appliedThis outcome measurement will be estimated during session one. The outcome measure takes approximately 5 minutes to estimate.The perception threshold will be estimated for the electrical stimuli with pulse shape 4 when anti-histamine cream has been applied for approximately an hour. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Perception threshold for pulse shape 1 when local anaesthetic cream has been appliedThis outcome measurement will be estimated during session two. The outcome measure takes approximately 5 minutes to estimate.The perception threshold will be estimated for the electrical stimuli with pulse shape 1 when local anaesthetic cream has been applied for approximately an hour. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Perception threshold for pulse shape 2 when local anaesthetic cream has been appliedThis outcome measurement will be estimated during session two. The outcome measure takes approximately 5 minutes to estimate.The perception threshold will be estimated for the electrical stimuli with pulse shape 2 when local anaesthetic cream has been applied for approximately an hour. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Perception threshold for pulse shape 3 when local anaesthetic cream has been appliedThis outcome measurement will be estimated during session two. The outcome measure takes approximately 5 minutes to estimate.The perception threshold will be estimated for the electrical stimuli with pulse shape 3 when local anaesthetic cream has been applied for approximately an hour. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Perception threshold for pulse shape 4 when local anaesthetic cream has been appliedThis outcome measurement will be estimated during session two. The outcome measure takes approximately 5 minutes to estimate.The perception threshold will be estimated for the electrical stimuli with pulse shape 4 when local anaesthetic cream has been applied for approximately an hour. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Sensation for pulse 1This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.The investigator will ask the participant to rate the sensation of electrical stimulation with pulse 1 for the three different conditions. The conditions are: control (not active cream), antihistamine cream, and local anesthetic cream. The scale is 0-10 for the three sensations touch, itch, and pain. Zero means no sensation, and ten is the worst pain/touch/itch imaginable.
Sensation for pulse 2This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.The investigator will ask the participant to rate the sensation of electrical stimulation with pulse 2 for the three different conditions. The conditions are: control (not active cream), antihistamine cream, and local anesthetic cream. The scale is 0-10 for the three sensations touch, itch, and pain. Zero means no sensation, and ten is the worst pain/touch/itch imaginable.
Sensation for pulse 3This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.The investigator will ask the participant to rate the sensation of electrical stimulation with pulse 3 for the three different conditions. The conditions are: control (not active cream), antihistamine cream, and local anesthetic cream. The scale is 0-10 for the three sensations touch, itch, and pain. Zero means no sensation, and ten is the worst pain/touch/itch imaginable.
Sensation for pulse 4This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.The investigator will ask the participant to rate the sensation of electrical stimulation with pulse 4 for the three different conditions. The conditions are: control (not active cream), antihistamine cream, and local anesthetic cream. The scale is 0-10 for the three sensations touch, itch, and pain. Zero means no sensation, and ten is the worst pain/touch/itch imaginable.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026