Testing Protocol for Cold-sensing Fibers

NCT05192577 | Completed DMC

• 1 other identifier: N-20200014 5-subproject
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain

Outcome Measures

Primary Outcomes (11)

• 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.

Study Arms (1)

Study group

EXPERIMENTAL

Other: Electrical stimulation

Interventions

Electrical stimulation OTHER

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.

Study group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy men and women
• years
• Speak and understand English

You may not qualify if:

• 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).

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Aalborg university

Aalborg, North Denmark, 9220, Denmark

Location

MeSH Terms

Conditions

Pain

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Jenny Tigerholm

  Aalborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: January 14, 2022
• Study Start: November 24, 2021
• Primary Completion: January 30, 2023
• Study Completion: July 3, 2023
• Last Updated: August 2, 2023

Record last verified: 2023-08

Locations

DK (1)