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Completed

NCT Number: NCT05127200

Cervical Neuromodulation and Nociceptive Processing

Several studies have demonstrated that direct currents delivered through the skin at the level of the lumbar spinal cord can influence spinal cord function. In human volunteers, anodal lumbar transcutaneous spinal direct current stimulation (tsDCS) alters spinal processing of nociceptive inputs. Whether cervical tsDCS is able to do the same is less well known.

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NOCIONS lab

Brussels, 1200, Belgium

About this study

The investigators will compare the effects on the nociceptive processing of healthy volunteers of cervical and lumbar tsDCS. This study will be a double-blinded, sham-controlled, cross-over trial. Each participant will undergo two experimental sessions (anodal cervical tsDCS and sham lumbar tsDCS vs. sham cervical tsDCS and anodal lumbar tsDCS), separated by at least one week.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy young adults

Exclusion criteria

  • Known medical conditions (e.g., diabetes, neuropathy, psychiatric disorders, seizure, migraine, pacemaker or other implanted medical devices...)
  • Use of any medication (except contraception)

Treatment and study plan

Starstim (Neuroelectrics)

Device

Anodal transcutaneous spinal direct current stimulation (a-tsDCS)

Primary outcomes

  1. Change in contact-heat evoked potentials amplitude

    Time frame: Change from Baseline, at 15-minutes after the end of stimulation

    N2/P2 amplitude

Secondary outcomes

  1. Change in intensity of perception to contact-heat nociceptive stimuli

    Time frame: Change from Baseline, at 15-minutes after the end of stimulation

    Difference in temperature (°C) needed to elicit a pain sensation of similar intensity in the upper and lower limb

  2. Change in temporal summation of pain

    Time frame: Change from Baseline, at 15-minutes after the end of stimulation

    Wind-up ratio (WUR) to mechanical pinprick stimuli

  3. Change in intensity of perception to mechanical pinprick nociceptive stimuli

    Time frame: Change from Baseline, at 15-minutes after the end of stimulation

    Numerical rating scale (0-100)

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Official study title

Effect of the Neuromodulation of the Cervical Spinal Cord on Nociceptive Processing in Healthy Volunteers - a Randomized, Double-blinded Study

Acronym: MICROVOLT

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 19, 2021
Registry last updated
Jul 7, 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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