Clinical trial NCT05195177: Testing Protocol to Efficiently Induce Itch
Official title: Nerve Excitability Testing Protocol to Efficiently Induce Itch
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Itch
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).


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).

Primary outcomes:
measure: Perception threshold for pulse shape 1
timeFrame: This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
measure: Perception threshold for pulse shape 2
timeFrame: This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
measure: Perception threshold for pulse shape 3
timeFrame: This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
measure: Perception threshold for pulse shape 4
timeFrame: This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
measure: Perception threshold for pulse shape 1 when antihistamine cream has been applied
timeFrame: This outcome measurement will be estimated during session one. The outcome measure takes approximately 5 minutes to estimate.
measure: Perception threshold for pulse shape 2 when anti-histamine cream has been applied
timeFrame: This outcome measurement will be estimated during session one. The outcome measure takes approximately 5 minutes to estimate.
measure: Perception threshold for pulse shape 3 when anti-histamine cream has been applied
timeFrame: This outcome measurement will be estimated during session one. The outcome measure takes approximately 5 minutes to estimate.
measure: Perception threshold for pulse shape 4 when anti-histamine cream has been applied
timeFrame: This outcome measurement will be estimated during session one. The outcome measure takes approximately 5 minutes to estimate.
measure: Perception threshold for pulse shape 1 when local anaesthetic cream has been applied
timeFrame: This outcome measurement will be estimated during session two. The outcome measure takes approximately 5 minutes to estimate.
measure: Perception threshold for pulse shape 2 when local anaesthetic cream has been applied
timeFrame: This outcome measurement will be estimated during session two. The outcome measure takes approximately 5 minutes to estimate.
measure: Perception threshold for pulse shape 3 when local anaesthetic cream has been applied
timeFrame: This outcome measurement will be estimated during session two. The outcome measure takes approximately 5 minutes to estimate.
measure: Perception threshold for pulse shape 4 when local anaesthetic cream has been applied
timeFrame: This outcome measurement will be estimated during session two. The outcome measure takes approximately 5 minutes to estimate.
measure: Sensation for pulse 1
timeFrame: This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
measure: Sensation for pulse 2
timeFrame: This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
measure: Sensation for pulse 3
timeFrame: This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
measure: Sensation for pulse 4
timeFrame: This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
state: Aalborg Ø
Study officials:
affiliation: Aalborg University
name: Jenny Tigerholm
role: PRINCIPAL_INVESTIGATOR
References: