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Clinical Trials/NCT06367777
NCT06367777RecruitingNot Applicable

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

Université Catholique de Louvain1 site in 1 country24 target enrollmentStarted: June 19, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
24
Locations
1
Primary Endpoint
Change in contact-heat evoked potentials amplitude

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Arms & Interventions

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.

Intervention: cervical a-tsDCS (Device)

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.

Intervention: thoracic a-tsDCS (Device)

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.

Intervention: sham tsDCS (Device)

Outcomes

Primary Outcomes

Change in contact-heat evoked potentials amplitude

Time Frame: Throughout the entire study, approximately during 6 months

N2 amplitude

Secondary Outcomes

  • Change in intensity of perception to contact-heat nociceptive stimuli(Throughout the entire study, approximately during 6 months)
  • Change in cutaneous blood flow(Throughout the entire study, approximately during 6 months)
  • Change in skin temperature(Throughout the entire study, approximately during 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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