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Testing Protocol for Cold-sensing Fibers

Nerve Excitability Testing Protocol for Cold-sensing Fibers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05192577
Acronym
Cold
Enrollment
20
Registered
2022-01-14
Start date
2021-11-24
Completion date
2023-07-03
Last updated
2023-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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).

Interventions

OTHERElectrical 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.

Sponsors

Aalborg University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
The sensation of pulse 1During session 1. The estimation of the outcome measurement take approximately 3 minutes.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.
Cold detection thresholdDuring session 1. The estimation of the outcome measurement take approximately 3 minutes.The cold detection threshold will be estimated by reducing the temperature until the subjects perceive a cold sensation.
Cold detection threshold with conditioning electrical stimuliDuring session 1. The estimation of the outcome measurement take approximately 3 minutes.The cold detection threshold will be estimated by reducing the temperature until the subjects perceive a cold sensation. Simultaneous will electrical stimulation be applied.
Warm detection thresholdDuring session 1. The estimation of the outcome measurement take approximately 3 minutes.The warm detection threshold will be estimated by increasing the temperature until the subjects perceive a warm sensation.
Warm detection threshold with conditioning electrical stimuliDuring session 1. The estimation of the outcome measurement take approximately 3 minutes.The warm detection threshold will be estimated by increasing the temperature until the subjects perceive a warm sensation. Simultaneous will electrical stimulation be applied.
Warm pain thresholdDuring session 1. The estimation of the outcome measurement take approximately 3 minutes.The warm pain threshold will be estimated by increasing the temperature until the subjects perceive a painful warm sensation.
Warm pain threshold with conditioning electrical stimuliDuring session 1. The estimation of the outcome measurement take approximately 3 minutes.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.
Cold pain thresholdDuring session 1. The estimation of the outcome measurement take approximately 3 minutes.The cold pain threshold will be estimated by reducing the temperature until the subjects perceive a painful warm sensation.
Cold pain threshold with conditioning electrical stimuliDuring session 1. The estimation of the outcome measurement take approximately 3 minutes.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.
The sensation of pulse 2During session 1. The estimation of the outcome measurement take approximately 3 minutes.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.
Perception thresholdDuring session 1. The estimation of the outcome measurement take approximately 15 minutes.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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026