Testing Protocol to Efficiently Induce Itch

Not Applicable

• Conditions: Itch
• Interventions: Drug: Anti-histamine cream 1 hour; Drug: Local anesthetic cream 1 hour

• Registration Number: NCT05195177
• Lead Sponsor: Aalborg University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-23
• Study Start: 2021-11-25
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-18
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-02
• Primary Completion: 2023-12-20
• Study Completion: 2023-12-20

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	Anti-histamine cream 1 hour	-
Study group	Local anesthetic cream 1 hour	-

Primary Outcome Measures

Name	Time	Method
Perception threshold for pulse shape 1	This 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 2	This 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 3	This 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 4	This 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 applied	This 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 applied	This 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 applied	This 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 applied	This 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 applied	This 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 applied	This 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 applied	This 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 applied	This 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 1	This 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 3	This 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 4	This 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.
Sensation for pulse 2	This 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.

Trial Locations

Locations (1)

Aalborg University; 🇩🇰 Aalborg, Aalborg Ø, Denmark