Cervical/Thoracic Neuromodulation and Nociceptive Processing (MICROVOLT2)

April 11, 2024 updated by: Université Catholique de Louvain

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

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 Contact

Study Contact Backup

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

  • 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 cervical tsDCS

Participants will receive:

  1. 20 minutes of 2.5 milliamperes (mA) anodal tsDCS at the cervical level.
  2. 20 minutes of sham tsDCS at the low-thoracic level.
Device: cervical a-tsDCS
Anodal transcutaneous spinal direct current stimulation (a-tsDCS)
Experimental: Anodal thoracic tsDCS

Participants will receive:

  1. 20 minutes of sham tsDCS at the cervical level.
  2. 20 minutes of 2.5 milliamperes (mA) anodal tsDCS at the low-thoracic level.
Device: thoracic a-tsDCS
Anodal transcutaneous spinal direct current stimulation (a-tsDCS)
Sham Comparator: Sham tsDCS

Participants will receive:

  1. 20 minutes of sham tsDCS at the cervical level.
  2. 20 minutes of sham tsDCS at the low-thoracic level.
Device: sham tsDCS
Sham transcutaneous spinal direct current stimulation (s-tsDCS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in contact-heat evoked potentials amplitude
Time Frame: Throughout the entire study, approximately during 6 months
N2 amplitude
Throughout the entire study, approximately during 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in intensity of perception to contact-heat nociceptive stimuli
Time Frame: Throughout the entire study, approximately during 6 months
Numerical rating scale (0-100)
Throughout the entire study, approximately during 6 months
Change in skin temperature
Time Frame: Throughout the entire study, approximately during 6 months
Temperature (°C)
Throughout the entire study, approximately during 6 months
Change in cutaneous blood flow
Time Frame: Throughout the entire study, approximately during 6 months
LDF flow (PU)
Throughout the entire study, approximately during 6 months

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

Helpful Links

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 (Estimated)

May 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

April 11, 2024

First Submitted That Met QC Criteria

April 11, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/14MAR/132

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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