Clinical trial NCT05192577: Testing Protocol for Cold-sensing Fibers
Official title: Nerve Excitability Testing Protocol for Cold-sensing Fibers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2022-01-14
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 project aims to evaluate whether electrical stimulation can modulate the cold detection threshold and the cold pain threshold. The hypothesis is that different electrical stimulation will either decrease or increase the cold threshold depending on the shape of the electrical stimulus. If a combination of electrical stimuli and cold stimuli could be used, this could lead to a novel method for estimating the excitability properties of cold-sensing fibers. The sub-project takes place in 1 session (1.5 hours).


Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* 18-80 years
* Speak and understand English

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: Cold detection threshold
timeFrame: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
measure: Cold detection threshold with conditioning electrical stimuli
timeFrame: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
measure: Warm detection threshold
timeFrame: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
measure: Warm detection threshold with conditioning electrical stimuli
timeFrame: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
measure: Warm pain threshold
timeFrame: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
measure: Warm pain threshold with conditioning electrical stimuli
timeFrame: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
measure: Cold pain threshold
timeFrame: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
measure: Cold pain threshold with conditioning electrical stimuli
timeFrame: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
measure: The sensation of pulse 1
timeFrame: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
measure: The sensation of pulse 2
timeFrame: During session 1. The estimation of the outcome measurement take approximately 3 minutes.
measure: Perception threshold
timeFrame: During session 1. The estimation of the outcome measurement take approximately 15 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg university
state: Nordjylland
Study officials:
affiliation: Aalborg University
name: Jenny Tigerholm
role: PRINCIPAL_INVESTIGATOR
References: