Cervical Neuromodulation and Nociceptive Processing

NCT05127200 | Completed

• 1 other identifier: 2021/02SEP/359
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Nociceptive Pain

Keywords

tsDCS; non-invasive neuromodulation; healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Change in contact-heat evoked potentials amplitude

  N2/P2 amplitude

  Change from Baseline, at 15-minutes after the end of stimulation

Secondary Outcomes (3)

• Change in intensity of perception to contact-heat nociceptive stimuli

  Change from Baseline, at 15-minutes after the end of stimulation

• Change in temporal summation of pain

  Change from Baseline, at 15-minutes after the end of stimulation

• Change in intensity of perception to mechanical pinprick nociceptive stimuli

  Change from Baseline, at 15-minutes after the end of stimulation

Study Arms (2)

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.

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.

Device: Starstim (Neuroelectrics)

Interventions

Starstim (Neuroelectrics) DEVICE

Anodal transcutaneous spinal direct current stimulation (a-tsDCS)

Anodal tsDCS (cervical active, lumbar sham); Anodal tsDCS (cervical sham, lumbar active)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Healthy young adults

You may not qualify if:

• Known medical conditions (e.g., diabetes, neuropathy, psychiatric disorders, seizure, migraine, pacemaker or other implanted medical devices...)
• Use of any medication (except contraception)

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

NOCIONS lab

Brussels, 1200, Belgium

Location

Related 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.

  PMID: 30321585 BACKGROUND

MeSH Terms

Conditions

Nociceptive Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• André Mouraux, MD, PhD

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: November 19, 2021
• Study Start: May 24, 2022
• Primary Completion: December 5, 2022
• Study Completion: December 5, 2022
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)