Cervical Neuromodulation and Nociceptive Processing (MICROVOLT)

July 6, 2023 updated by: Université Catholique de Louvain

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • NOCIONS lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anodal tsDCS (cervical active, lumbar sham)

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 transcutaneous spinal direct current stimulation (a-tsDCS)
Active Comparator: Anodal tsDCS (cervical sham, lumbar active)

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)
Anodal transcutaneous spinal direct current stimulation (a-tsDCS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in contact-heat evoked potentials amplitude
Time Frame: Change from Baseline, at 15-minutes after the end of stimulation
N2/P2 amplitude
Change from Baseline, at 15-minutes after the end of stimulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in intensity of perception to contact-heat nociceptive stimuli
Time Frame: 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
Change from Baseline, at 15-minutes after the end of stimulation
Change in temporal summation of pain
Time Frame: Change from Baseline, at 15-minutes after the end of stimulation
Wind-up ratio (WUR) to mechanical pinprick stimuli
Change from Baseline, at 15-minutes after the end of stimulation
Change in intensity of perception to mechanical pinprick nociceptive stimuli
Time Frame: Change from Baseline, at 15-minutes after the end of stimulation
Numerical rating scale (0-100)
Change from Baseline, at 15-minutes after the end of stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université Catholique de Louvain

Investigators

  • Principal Investigator: André Mouraux, MD, PhD, Université Catholique de Louvain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2022

Primary Completion (Actual)

December 5, 2022

Study Completion (Actual)

December 5, 2022

Study Registration Dates

First Submitted

October 5, 2021

First Submitted That Met QC Criteria

November 8, 2021

First Posted (Actual)

November 19, 2021

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

July 6, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/02SEP/359

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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