Testing Protocol to Efficiently Induce Itch

Itch Clinical Trial

— ELIT  

Official title:

Nerve Excitability Testing Protocol to Efficiently Induce Itch

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05195177
• Other study ID #: N-2020001 4-sub-project
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 25, 2021
• Est. completion date: December 20, 2023

Study information

• Verified date: August 2023
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Itch

Intervention

Drug:
• Anti-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.
• Local 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.

Locations

Country	Name	City	State
Denmark	Aalborg University	Aalborg	Aalborg Ø

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perception threshold for pulse shape 1	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.	This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
Primary	Perception threshold for pulse shape 2	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.	This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
Primary	Perception threshold for pulse shape 3	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.	This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
Primary	Perception threshold for pulse shape 4	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.	This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
Primary	Perception threshold for pulse shape 1 when antihistamine cream has been applied	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.	This outcome measurement will be estimated during session one. The outcome measure takes approximately 5 minutes to estimate.
Primary	Perception threshold for pulse shape 2 when anti-histamine cream has been applied	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.	This outcome measurement will be estimated during session one. The outcome measure takes approximately 5 minutes to estimate.
Primary	Perception threshold for pulse shape 3 when anti-histamine cream has been applied	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.	This outcome measurement will be estimated during session one. The outcome measure takes approximately 5 minutes to estimate.
Primary	Perception threshold for pulse shape 4 when anti-histamine cream has been applied	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.	This outcome measurement will be estimated during session one. The outcome measure takes approximately 5 minutes to estimate.
Primary	Perception threshold for pulse shape 1 when local anaesthetic cream has been applied	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.	This outcome measurement will be estimated during session two. The outcome measure takes approximately 5 minutes to estimate.
Primary	Perception threshold for pulse shape 2 when local anaesthetic cream has been applied	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.	This outcome measurement will be estimated during session two. The outcome measure takes approximately 5 minutes to estimate.
Primary	Perception threshold for pulse shape 3 when local anaesthetic cream has been applied	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.	This outcome measurement will be estimated during session two. The outcome measure takes approximately 5 minutes to estimate.
Primary	Perception threshold for pulse shape 4 when local anaesthetic cream has been applied	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.	This outcome measurement will be estimated during session two. The outcome measure takes approximately 5 minutes to estimate.
Primary	Sensation for pulse 1	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.	This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
Primary	Sensation for pulse 2	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.	This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
Primary	Sensation for pulse 3	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.	This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
Primary	Sensation for pulse 4	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.	This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.