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Clinical Trials/NCT05195177
NCT05195177
Enrolling By Invitation
Not Applicable

Nerve Excitability Testing Protocol to Efficiently Induce Itch

Aalborg University1 site in 1 country20 target enrollmentNovember 25, 2021

Overview

Phase
Not Applicable
Intervention
Anti-histamine cream 1 hour
Conditions
Itch
Sponsor
Aalborg University
Enrollment
20
Locations
1
Primary Endpoint
Perception threshold for pulse shape 1
Status
Enrolling By Invitation
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
November 25, 2021
End Date
December 20, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Aalborg University
Responsible Party
Principal Investigator
Principal Investigator

Jenny Tigerholm

Assistant Professor

Aalborg University

Eligibility Criteria

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

Arms & Interventions

Study group

Intervention: Anti-histamine cream 1 hour

Study group

Intervention: Local anesthetic cream 1 hour

Outcomes

Primary Outcomes

Perception threshold for pulse shape 1

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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