Nociceptive PainMICROVOLTNCT05127200
Cervical Neuromodulation and Nociceptive Processing
A study testing Starstim (Neuroelectrics) 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 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. 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?
- Starstim (Neuroelectrics)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 24 May 2022to 5 Dec 2022
- 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: Effect of the Neuromodulation of the Cervical Spinal Cord on Nociceptive Processing in Healthy Volunteers - a Randomized, Double-blinded Study
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.
Read the detailed description
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.
- Conditions
- Nociceptive Pain
- Being tested
- Starstim (Neuroelectrics)
- 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.
Starstim (Neuroelectrics)Device
Anodal transcutaneous spinal direct current stimulation (a-tsDCS)
| Study group | Role | What they receive |
|---|---|---|
| Anodal tsDCS (cervical active, lumbar sham) | Experimental | Participants will receive:
1. 20 minutes of 2.5 milliampere (mA) anodal tsDCS at the cervical level.
2. sham tsDCS at the lumbar level. Receives: Device: Starstim (Neuroelectrics) |
| Anodal tsDCS (cervical sham, lumbar active) | Active comparator | Participants will receive:
1. 20 minutes of 2.5 milliampere (mA) anodal tsDCS at the lumbar level.
2. sham tsDCS at the cervical level. Receives: Device: Starstim (Neuroelectrics) |
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/P2 amplitude
Measured: Change from Baseline, at 15-minutes after the end of stimulation
Secondary outcomes (3)
Change in intensity of perception to contact-heat nociceptive stimuli
Difference in temperature (°C) needed to elicit a pain sensation of similar intensity in the upper and lower limb
Measured: Change from Baseline, at 15-minutes after the end of stimulation
Change in temporal summation of pain
Wind-up ratio (WUR) to mechanical pinprick stimuli
Measured: Change from Baseline, at 15-minutes after the end of stimulation
Change in intensity of perception to mechanical pinprick nociceptive stimuli
Numerical rating scale (0-100)
Measured: Change from Baseline, at 15-minutes after the end of stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start24 May 2022
- Primary completion5 Dec 2022
- Study completion5 Dec 2022
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.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- 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 (actual)
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
- NCT05127200
- Sponsor's protocol ID
- 2021/02SEP/359
- Acronym
- MICROVOLT
- Status last verified
- Jul 2023
- First submitted
- 5 Oct 2021
- Last updated
- 7 Jul 2023
- 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 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Neuromodulation of the Cervical Spinal Cord on Nociceptive Processing in Healthy Volunteers - a Randomized, Double-blinded Study
- ClinicalTrials.gov ID
- NCT05127200
- Acronym / sponsor ID
- MICROVOLT / 2021/02SEP/359
- Conditions
- Nociceptive Pain
- Keywords
- tsDCS, non-invasive neuromodulation, healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 19 Nov 2021 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal tsDCS (cervical active, lumbar sham) | Experimental | Device: Starstim (Neuroelectrics)Participants will receive: 1. 20 minutes of 2.5 milliampere (mA) anodal tsDCS at the cervical level. 2. sham tsDCS at the lumbar level. |
| Anodal tsDCS (cervical sham, lumbar active) | Active comparator | Device: Starstim (Neuroelectrics)Participants will receive: 1. 20 minutes of 2.5 milliampere (mA) anodal tsDCS at the lumbar level. 2. sham tsDCS at the cervical 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 |
|---|---|---|
| Starstim (Neuroelectrics)Anodal transcutaneous spinal direct current stimulation (a-tsDCS) | Device | Anodal tsDCS (cervical active, lumbar sham), Anodal tsDCS (cervical sham, lumbar active) |
Primary outcome
Change in contact-heat evoked potentials amplitude
Time frame: Change from Baseline, at 15-minutes after the end of stimulation
N2/P2 amplitude
3 secondary outcomes
Change in intensity of perception to contact-heat nociceptive stimuli
Time frame: Change from Baseline, at 15-minutes after the end of stimulation
Change in temporal summation of pain
Time frame: Change from Baseline, at 15-minutes after the end of stimulation
Change in intensity of perception to mechanical pinprick nociceptive stimuli
Time frame: Change from Baseline, at 15-minutes after the end of stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- 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.
- 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 Starstim (Neuroelectrics) 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: finished, as of the sponsor's last update on 7 Jul 2023. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in contact-heat evoked potentials amplitude (time frame: Change from Baseline, at 15-minutes after the end of stimulation). 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 NCT05127200, 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 7 Jul 2023.