Testing Protocol for Cold-sensing Fibers (Cold)

Nerve Excitability Testing Protocol for Cold-sensing Fibers

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).

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Other: Electrical stimulation

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Nordjylland
    • Aalborg, Nordjylland, Denmark, 9220
      • Aalborg University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Aalborg University
• Investigators: Principal Investigator: Jenny Tigerholm, Aalborg University

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2021
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): July 3, 2023

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: N-20200014 5-subproject

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No