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Completed

NCT Number: NCT05192577

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).

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg university

Aalborg, North Denmark, 9220, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Cold detection threshold

    Time frame: During 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.

  2. Cold detection threshold with conditioning electrical stimuli

    Time frame: During 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.

  3. Warm detection threshold

    Time frame: During 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.

  4. Warm detection threshold with conditioning electrical stimuli

    Time frame: During 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.

  5. Warm pain threshold

    Time frame: During 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.

  6. Warm pain threshold with conditioning electrical stimuli

    Time frame: During 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.

  7. Cold pain threshold

    Time frame: During 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.

  8. Cold pain threshold with conditioning electrical stimuli

    Time frame: During 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.

  9. The sensation of pulse 1

    Time frame: During 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.

  10. The sensation of pulse 2

    Time frame: During 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.

  11. Perception threshold

    Time frame: During 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.

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study title

Nerve Excitability Testing Protocol for Cold-sensing Fibers

Acronym: Cold

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 14, 2022
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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