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Cervical Neuromodulation and Nociceptive Processing (MICROVOLT)

Primary Purpose

Nociceptive Pain

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Starstim (Neuroelectrics)
Sponsored by
Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Nociceptive Pain focused on measuring tsDCS, non-invasive neuromodulation, healthy volunteers

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • NOCIONS lab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Anodal tsDCS (cervical active, lumbar sham)

Anodal tsDCS (cervical sham, lumbar active)

Arm Description

Participants will receive: 20 minutes of 2.5 milliampere (mA) anodal tsDCS at the cervical level. sham tsDCS at the lumbar level.

Participants will receive: 20 minutes of 2.5 milliampere (mA) anodal tsDCS at the lumbar level. sham tsDCS at the cervical level.

Outcomes

Primary Outcome Measures

Change in contact-heat evoked potentials amplitude
N2/P2 amplitude

Secondary Outcome Measures

Change in intensity of perception to contact-heat nociceptive stimuli
Difference in temperature (°C) needed to elicit a pain sensation of similar intensity in the upper and lower limb
Change in temporal summation of pain
Wind-up ratio (WUR) to mechanical pinprick stimuli
Change in intensity of perception to mechanical pinprick nociceptive stimuli
Numerical rating scale (0-100)

Full Information

First Posted
October 5, 2021
Last Updated
July 6, 2023
Sponsor
Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT05127200
Brief Title
Cervical Neuromodulation and Nociceptive Processing
Acronym
MICROVOLT
Official Title
Effect of the Neuromodulation of the Cervical Spinal Cord on Nociceptive Processing in Healthy Volunteers - a Randomized, Double-blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 24, 2022 (Actual)
Primary Completion Date
December 5, 2022 (Actual)
Study Completion Date
December 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nociceptive Pain
Keywords
tsDCS, non-invasive neuromodulation, healthy volunteers

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anodal tsDCS (cervical active, lumbar sham)
Arm Type
Experimental
Arm Description
Participants will receive: 20 minutes of 2.5 milliampere (mA) anodal tsDCS at the cervical level. sham tsDCS at the lumbar level.
Arm Title
Anodal tsDCS (cervical sham, lumbar active)
Arm Type
Active Comparator
Arm Description
Participants will receive: 20 minutes of 2.5 milliampere (mA) anodal tsDCS at the lumbar level. sham tsDCS at the cervical level.
Intervention Type
Device
Intervention Name(s)
Starstim (Neuroelectrics)
Intervention Description
Anodal transcutaneous spinal direct current stimulation (a-tsDCS)
Primary Outcome Measure Information:
Title
Change in contact-heat evoked potentials amplitude
Description
N2/P2 amplitude
Time Frame
Change from Baseline, at 15-minutes after the end of stimulation
Secondary Outcome Measure Information:
Title
Change in intensity of perception to contact-heat nociceptive stimuli
Description
Difference in temperature (°C) needed to elicit a pain sensation of similar intensity in the upper and lower limb
Time Frame
Change from Baseline, at 15-minutes after the end of stimulation
Title
Change in temporal summation of pain
Description
Wind-up ratio (WUR) to mechanical pinprick stimuli
Time Frame
Change from Baseline, at 15-minutes after the end of stimulation
Title
Change in intensity of perception to mechanical pinprick nociceptive stimuli
Description
Numerical rating scale (0-100)
Time Frame
Change from Baseline, at 15-minutes after the end of stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André Mouraux, MD, PhD
Organizational Affiliation
Université Catholique de Louvain
Official's Role
Principal Investigator
Facility Information:
Facility Name
NOCIONS lab
City
Brussels
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30321585
Citation
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.
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Cervical Neuromodulation and Nociceptive Processing

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