Cervical/Thoracic Neuromodulation and Nociceptive Processing

Nociceptive Pain Clinical Trial

— MICROVOLT2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06367777
• Other study ID #: 2024/14MAR/132
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2024
• Est. completion date: October 2024

Study information

• Verified date: June 2024
• Source: Université Catholique de Louvain
• Contact: André Mouraux, MD, PhD
• Phone: +3227645361
• Email: andre.mouraux[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Nociceptive Pain

Intervention

Device:
• cervical a-tsDCS
Anodal transcutaneous spinal direct current stimulation (a-tsDCS)
• thoracic a-tsDCS
Anodal transcutaneous spinal direct current stimulation (a-tsDCS)
• sham tsDCS
Sham transcutaneous spinal direct current stimulation (s-tsDCS)

Locations

Country	Name	City	State
Belgium	UCLouvain	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in contact-heat evoked potentials amplitude	N2 amplitude	Throughout the entire study, approximately during 6 months
Secondary	Change in intensity of perception to contact-heat nociceptive stimuli	Numerical rating scale (0-100)	Throughout the entire study, approximately during 6 months
Secondary	Change in skin temperature	Temperature (°C)	Throughout the entire study, approximately during 6 months
Secondary	Change in cutaneous blood flow	LDF flow (PU)	Throughout the entire study, approximately during 6 months

External Links

•   NOCIONS lab website