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Cervical/Thoracic Neuromodulation and Nociceptive Processing

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06367777
Acronym
MICROVOLT2
Enrollment
24
Registered
2024-04-16
Start date
2024-06-19
Completion date
2024-10-31
Last updated
2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nociceptive Pain

Keywords

tsDCS, non-invasive neuromodulation, healthy volunteers

Brief 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.

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.

Interventions

DEVICEcervical a-tsDCS

Anodal transcutaneous spinal direct current stimulation (a-tsDCS)

DEVICEthoracic a-tsDCS

Anodal transcutaneous spinal direct current stimulation (a-tsDCS)

Sham transcutaneous spinal direct current stimulation (s-tsDCS)

Sponsors

Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in contact-heat evoked potentials amplitudeThroughout the entire study, approximately during 6 monthsN2 amplitude

Secondary

MeasureTime frameDescription
Change in intensity of perception to contact-heat nociceptive stimuliThroughout the entire study, approximately during 6 monthsNumerical rating scale (0-100)
Change in skin temperatureThroughout the entire study, approximately during 6 monthsTemperature (°C)
Change in cutaneous blood flowThroughout the entire study, approximately during 6 monthsLDF flow (PU)

Countries

Belgium

Contacts

Primary ContactAndré Mouraux, MD, PhD
andre.mouraux@uclouvain.be+3227645361
Backup ContactArnaud Steyaert, MD
arnaud.steyaert@uclouvain.be+3227641821

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026