Testing Protocol for Cold-sensing Fibers

Pain Clinical Trial

— Cold  

Official title:

Nerve Excitability Testing Protocol for Cold-sensing Fibers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05192577
• Other study ID #: N-20200014 5-subproject
• Status: Completed
• Phase: N/A
• Start date: November 24, 2021
• Est. completion date: July 3, 2023

Study information

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

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 3, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Electrical stimulation
At the beginning of the session, an electrode will be attached to the participant's ankle. Electrical stimulation will be applied to estimate the electrical perception threshold. This threshold will be used as condition stimuli when different thermal thresholds are assessed.

Locations

Country	Name	City	State
Denmark	Aalborg university	Aalborg	Nordjylland

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cold detection threshold	The cold detection threshold will be estimated by reducing the temperature until the subjects perceive a cold sensation.	During session 1. The estimation of the outcome measurement take approximately 3 minutes.
Primary	Cold detection threshold with conditioning electrical stimuli	The cold detection threshold will be estimated by reducing the temperature until the subjects perceive a cold sensation. Simultaneous will electrical stimulation be applied.	During session 1. The estimation of the outcome measurement take approximately 3 minutes.
Primary	Warm detection threshold	The warm detection threshold will be estimated by increasing the temperature until the subjects perceive a warm sensation.	During session 1. The estimation of the outcome measurement take approximately 3 minutes.
Primary	Warm detection threshold with conditioning electrical stimuli	The warm detection threshold will be estimated by increasing the temperature until the subjects perceive a warm sensation. Simultaneous will electrical stimulation be applied.	During session 1. The estimation of the outcome measurement take approximately 3 minutes.
Primary	Warm pain threshold	The warm pain threshold will be estimated by increasing the temperature until the subjects perceive a painful warm sensation.	During session 1. The estimation of the outcome measurement take approximately 3 minutes.
Primary	Warm pain threshold with conditioning electrical stimuli	The warm pain threshold will be estimated by increasing the temperature until the subjects perceive a warm painful sensation. Simultaneous will electrical stimulation be applied.	During session 1. The estimation of the outcome measurement take approximately 3 minutes.
Primary	Cold pain threshold	The cold pain threshold will be estimated by reducing the temperature until the subjects perceive a painful warm sensation.	During session 1. The estimation of the outcome measurement take approximately 3 minutes.
Primary	Cold pain threshold with conditioning electrical stimuli	The cold pain threshold will be estimated by reducing the temperature until the subjects perceive a cold painful sensation. Simultaneous will electrical stimulation be applied.	During session 1. The estimation of the outcome measurement take approximately 3 minutes.
Primary	The sensation of pulse 1	The investigator will ask the participant to rate the sensation by a questionnaire. The scale will be 0-10, where 0 indicates no sensation and 10 is the worst imaginable sensation.	During session 1. The estimation of the outcome measurement take approximately 3 minutes.
Primary	The sensation of pulse 2	The investigater will ask the participant to rate the sensation by a questionnaire. The scale will be from 0-10 where 0 indication no sensation and 10 the worst imaginable sensation.	During session 1. The estimation of the outcome measurement take approximately 3 minutes.
Primary	Perception threshold	The Perception threshold for the cutaneous electrical stimulation will be estimated for two different pulse shapes of the electrical stimulus. The perception threshold is defined as the electrical current needed for the participant to perceive the stimulus. The perception threshold will be estimated by the method of limits.	During session 1. The estimation of the outcome measurement take approximately 15 minutes.