Cervical Neuromodulation and Nociceptive Processing

Not Applicable

Completed

• Conditions: Nociceptive Pain
• Interventions: Device: Starstim (Neuroelectrics)

• Registration Number: NCT05127200
• Lead Sponsor: Université Catholique de Louvain

Brief 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.

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 Timeline

• Study First Submitted: 2021-10-05
• Study First Submitted QC: 2021-11-08
• Study First Posted: 2021-11-19
• Study Start: 2022-05-24
• Primary Completion: 2022-12-05
• Study Completion: 2022-12-05
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-06
• Last Update Posted: 2023-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Anodal tsDCS (cervical active, lumbar sham)	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)	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.

Primary Outcome Measures

Name	Time	Method
Change in contact-heat evoked potentials amplitude	Change from Baseline, at 15-minutes after the end of stimulation	N2/P2 amplitude

Secondary Outcome Measures

Name	Time	Method
Change in temporal summation of pain	Change from Baseline, at 15-minutes after the end of stimulation	Wind-up ratio (WUR) to mechanical pinprick stimuli
Change in intensity of perception to mechanical pinprick nociceptive stimuli	Change from Baseline, at 15-minutes after the end of stimulation	Numerical rating scale (0-100)
Change in intensity of perception to contact-heat nociceptive stimuli	Change from Baseline, at 15-minutes after the end of stimulation	Difference in temperature (°C) needed to elicit a pain sensation of similar intensity in the upper and lower limb

Trial Locations

Locations (1)

NOCIONS lab; 🇧🇪 Brussels, Belgium