NCT06367777

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 19, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

April 11, 2024

Last Update Submit

June 20, 2024

Conditions

Nociceptive Pain

Keywords

tsDCSnon-invasive neuromodulationhealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Change in contact-heat evoked potentials amplitude

    N2 amplitude

    Throughout the entire study, approximately during 6 months

Secondary Outcomes (3)

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

    Throughout the entire study, approximately during 6 months

  • Change in skin temperature

    Throughout the entire study, approximately during 6 months

  • Change in cutaneous blood flow

    Throughout the entire study, approximately during 6 months

Study Arms (3)

Anodal cervical tsDCS

EXPERIMENTAL

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 thoracic tsDCS

EXPERIMENTAL

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

Sham tsDCS

SHAM COMPARATOR

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

Interventions

cervical a-tsDCSDEVICE

Anodal transcutaneous spinal direct current stimulation (a-tsDCS)

Anodal cervical tsDCS
thoracic a-tsDCSDEVICE

Anodal transcutaneous spinal direct current stimulation (a-tsDCS)

Anodal thoracic tsDCS
sham tsDCSDEVICE

Sham transcutaneous spinal direct current stimulation (s-tsDCS)

Sham tsDCS

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLouvain

Brussels, Belgium

RECRUITING

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: 30321585BACKGROUND

Related Links

MeSH Terms

Conditions

Nociceptive Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • André Mouraux, MD, PhD

    Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

André Mouraux, MD, PhD

CONTACT

+3227645361andre.mouraux@uclouvain.be

Arnaud Steyaert, MD

CONTACT

+3227641821arnaud.steyaert@uclouvain.be

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

April 11, 2024

First Posted

April 16, 2024

Study Start

June 19, 2024

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

June 21, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)