Nociceptive PainMICROVOLT2NCT06367777
Cervical/Thoracic Neuromodulation and Nociceptive Processing
A study testing cervical a-tsDCS and thoracic a-tsDCS in people with Nociceptive Pain, run by Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Nociceptive Pain
- What is being tested?
- cervical a-tsDCS and thoracic a-tsDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Jun 2024to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young adults
Who cannot join
- Known medical conditions (e.g., diabetes, neuropathy, psychiatric disorders, seizure, migraine, pacemaker or other implanted medical devices...)
- Use of any medication (except contraception)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effects of the Neuromodulation of the Cervical and the Low-thoracic Spinal Cord on Nociceptive Processing in Healthy Volunteers - an Randomized, Sham-controlled, Double-blinded Study
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.
- Conditions
- Nociceptive Pain
- Being tested
- cervical a-tsDCS, thoracic a-tsDCS, sham tsDCS
- Keywords
- tsDCS, non-invasive neuromodulation, healthy volunteers
- Medical subject headings
- Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical a-tsDCSDevice
Anodal transcutaneous spinal direct current stimulation (a-tsDCS)
thoracic a-tsDCSDevice
Anodal transcutaneous spinal direct current stimulation (a-tsDCS)
sham tsDCSDevice
Sham transcutaneous spinal direct current stimulation (s-tsDCS)
| Study group | Role | What they receive |
|---|---|---|
| Anodal cervical tsDCS | Experimental | 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. Receives: Device: cervical a-tsDCS |
| Anodal thoracic tsDCS | Experimental | 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. Receives: Device: thoracic a-tsDCS |
| Sham tsDCS | Sham comparator | Participants will receive:
1. 20 minutes of sham tsDCS at the cervical level.
2. 20 minutes of sham tsDCS at the low-thoracic level. Receives: Device: sham tsDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in contact-heat evoked potentials amplitude
N2 amplitude
Measured: Throughout the entire study, approximately during 6 months
Secondary outcomes (3)
Change in intensity of perception to contact-heat nociceptive stimuli
Numerical rating scale (0-100)
Measured: Throughout the entire study, approximately during 6 months
Change in skin temperature
Temperature (°C)
Measured: Throughout the entire study, approximately during 6 months
Change in cutaneous blood flow
LDF flow (PU)
Measured: Throughout the entire study, approximately during 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start19 Jun 2024
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nociceptive PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- André Mouraux, MD, PhD, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367777
- Sponsor's protocol ID
- 2024/14MAR/132
- Acronym
- MICROVOLT2
- Status last verified
- Jun 2024
- First submitted
- 11 Apr 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of the Neuromodulation of the Cervical and the Low-thoracic Spinal Cord on Nociceptive Processing in Healthy Volunteers - an Randomized, Sham-controlled, Double-blinded Study
- ClinicalTrials.gov ID
- NCT06367777
- Acronym / sponsor ID
- MICROVOLT2 / 2024/14MAR/132
- Conditions
- Nociceptive Pain
- Keywords
- tsDCS, non-invasive neuromodulation, healthy volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anodal cervical tsDCS | Experimental | Device: cervical a-tsDCSParticipants 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. |
| Anodal thoracic tsDCS | Experimental | Device: thoracic a-tsDCSParticipants 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. |
| Sham tsDCS | Sham comparator | Device: sham tsDCSParticipants will receive: 1. 20 minutes of sham tsDCS at the cervical level. 2. 20 minutes of sham tsDCS at the low-thoracic level. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy young adults
Key exclusion criteria (2 listed)
- Known medical conditions (e.g., diabetes, neuropathy, psychiatric disorders, seizure, migraine, pacemaker or other implanted medical devices...)
- Use of any medication (except contraception)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cervical a-tsDCSAnodal transcutaneous spinal direct current stimulation (a-tsDCS) | Device | Anodal cervical tsDCS |
| thoracic a-tsDCSAnodal transcutaneous spinal direct current stimulation (a-tsDCS) | Device | Anodal thoracic tsDCS |
| sham tsDCSSham transcutaneous spinal direct current stimulation (s-tsDCS) | Device | Sham tsDCS |
Primary outcome
Change in contact-heat evoked potentials amplitude
Time frame: Throughout the entire study, approximately during 6 months
N2 amplitude
3 secondary outcomes
Change in intensity of perception to contact-heat nociceptive stimuli
Time frame: Throughout the entire study, approximately during 6 months
Change in skin temperature
Time frame: Throughout the entire study, approximately during 6 months
Change in cutaneous blood flow
Time frame: Throughout the entire study, approximately during 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Background: PubMed 30321585Lenoir 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.
- NOCIONS lab websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
André Mouraux, MD, PhD principal investigator
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical a-tsDCS and thoracic a-tsDCS in people with Nociceptive Pain, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact André Mouraux, MD, PhD (+3227645361, andre.mouraux@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in contact-heat evoked potentials amplitude (time frame: Throughout the entire study, approximately during 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06367777, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024; AzTrials last refreshed its copy on 27 Oct 2026.