Cervical Neuromodulation and Nociceptive Processing

Nociceptive Pain Clinical Trial

— MICROVOLT  

Official title:

Effect of the Neuromodulation of the Cervical Spinal Cord on Nociceptive Processing in Healthy Volunteers - a Randomized, Double-blinded Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05127200
• Other study ID #: 2021/02SEP/359
• Status: Completed
• Phase: N/A
• Start date: May 24, 2022
• Est. completion date: December 5, 2022

Study information

• Verified date: July 2023
• Source: Université Catholique de Louvain
• Contact: n/a
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 5, 2022
• Est. primary completion date: December 5, 2022
• 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:
• Starstim (Neuroelectrics)
Anodal transcutaneous spinal direct current stimulation (a-tsDCS)

Locations

Country	Name	City	State
Belgium	NOCIONS lab	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/P2 amplitude	Change from Baseline, at 15-minutes after the end of stimulation
Secondary	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	Change from Baseline, at 15-minutes after the end of stimulation
Secondary	Change in temporal summation of pain	Wind-up ratio (WUR) to mechanical pinprick stimuli	Change from Baseline, at 15-minutes after the end of stimulation
Secondary	Change in intensity of perception to mechanical pinprick nociceptive stimuli	Numerical rating scale (0-100)	Change from Baseline, at 15-minutes after the end of stimulation