Testing Protocol to Efficiently Induce Itch

NCT ID: NCT05195177

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-25
• Study Completion Date: 2023-12-20

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).

Conditions

Itch

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Study group

Group Type: EXPERIMENTAL

Anti-histamine cream 1 hour

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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
• Patients with cardiac diseases (e.g., pacemaker).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aalborg University

OTHER

Sponsor Role: lead

Responsible Party

Jenny Tigerholm

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jenny Tigerholm

Role: PRINCIPAL_INVESTIGATOR

Aalborg University

Locations

Aalborg University

Aalborg, Aalborg Ø, Denmark

Countries

Denmark

Other Identifiers

N-2020001 4-sub-project

Identifier Type: -

Identifier Source: org_study_id