ClinicalTrials.gg
Status unknownNCT06367777MICROVOLT2Updated Jun 21, 2024

Cervical/Thoracic Neuromodulation and Nociceptive Processing

An interventional study of cervical a-tsDCS and thoracic a-tsDCS in Nociceptive Pain, sponsored by Université Catholique de Louvain. Status unknown at 1 site in Belgium. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-21.

Sponsored by Université Catholique de Louvain · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Jun 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
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Study summary

Several studies have demonstrated that direct currents delivered through the skin at the level of the low-thoracic spinal cord can influence spinal cord function. In human volunteers, anodal low-thoracic 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. In this double-blinded, sham-controlled and cross-over trial, the investigators will compare the effects on the nociceptive processing of healthy volunteers of cervical and low-thoracic tsDCS.

Read the detailed description

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

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Conditions studied

  • Nociceptive Pain

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Keywords

  • tsDCS
  • non-invasive neuromodulation
  • healthy volunteers
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In context

Nociceptive Pain

97 studies on the registry are indexed under Nociceptive Pain; 18 are open to participants now.

This study's planned enrollment of 24 is below the median of 60 across 66 interventional studies indexed under Nociceptive Pain.

Browse Nociceptive Pain studies →

Lead sponsor

Université Catholique de Louvain is the lead sponsor of 151 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Healthy young adults

Exclusion criteria

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)
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Anodal cervical tsDCS

    Participants will receive: 1. 20 minutes of 2.5 milliamperes (mA) anodal tsDCS at the cervical level. 2. 20 minutes of sham tsDCS at the low-thoracic level.

    Device: cervical a-tsDCS

  • Experimental
    Anodal thoracic tsDCS

    Participants will receive: 1. 20 minutes of sham tsDCS at the cervical level. 2. 20 minutes of 2.5 milliamperes (mA) anodal tsDCS at the low-thoracic level.

    Device: thoracic a-tsDCS

  • Sham comparator
    Sham tsDCS

    Participants will receive: 1. 20 minutes of sham tsDCS at the cervical level. 2. 20 minutes of sham tsDCS at the low-thoracic level.

    Device: sham tsDCS

Interventions

  • Devicecervical a-tsDCS

    Anodal transcutaneous spinal direct current stimulation (a-tsDCS)

  • Devicethoracic a-tsDCS

    Anodal transcutaneous spinal direct current stimulation (a-tsDCS)

  • Devicesham tsDCS

    Sham transcutaneous spinal direct current stimulation (s-tsDCS)

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What researchers measure

Primary outcomes

  1. Change in contact-heat evoked potentials amplitude

    N2 amplitude

    Time frame: Throughout the entire study, approximately during 6 months

Secondary outcomes

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

    Numerical rating scale (0-100)

    Time frame: Throughout the entire study, approximately during 6 months

  2. Change in skin temperature

    Temperature (°C)

    Time frame: Throughout the entire study, approximately during 6 months

  3. Change in cutaneous blood flow

    LDF flow (PU)

    Time frame: Throughout the entire study, approximately during 6 months

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Study locations

1 of 1 sites recruiting
  • UCLouvain
    Brussels, Belgium
    • André Mouraux, PhD · Contact
    Recruiting
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References and documents

Publications

  • Lenoir C, Jankovski A, Mouraux A. Anodal Transcutaneous Spinal Direct Current Stimulation (tsDCS) Selectively Inhibits the Synaptic Efficacy of Nociceptive Transmission at Spinal Cord Level. Neuroscience. 2018 Nov 21;393:150-163. doi: 10.1016/j.neuroscience.2018.10.007. Epub 2018 Oct 12. PubMed 30321585 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06367777
Responsible party
Sponsor
First posted
Apr 16, 2024
Start date
Jun 19, 2024
Primary completion
Oct 2024 (estimated)
Completion
Oct 2024 (estimated)
Last update
Jun 21, 2024

Study contacts

André Mouraux, MD, PhD
Contact
andre.mouraux@uclouvain.be
+3227645361
Arnaud Steyaert, MD
Contact
arnaud.steyaert@uclouvain.be
+3227641821
André Mouraux, MD, PhD
principal investigator · Université Catholique de Louvain

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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