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MICROVOLT: Cervical Neuromodulation and Nociceptive Processing

Sponsor
Université Catholique de Louvain (Other)
Overall Status
Recruiting
CT.gov ID
NCT05127200
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
4.3
Anticipated Duration (Months)
5.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Starstim (Neuroelectrics)
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Effect of the Neuromodulation of the Cervical Spinal Cord on Nociceptive Processing in Healthy Volunteers - a Randomized, Double-blinded Study
Actual Study Start Date :
May 24, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

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

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

Device: Starstim (Neuroelectrics)
Anodal transcutaneous spinal direct current stimulation (a-tsDCS)

Outcome Measures

Primary Outcome Measures

  1. Change in contact-heat evoked potentials amplitude [Change from Baseline, at 15-minutes after the end of stimulation]

    N2/P2 amplitude

Secondary Outcome Measures

  1. Change in intensity of perception to contact-heat nociceptive stimuli [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

  2. Change in temporal summation of pain [Change from Baseline, at 15-minutes after the end of stimulation]

    Wind-up ratio (WUR) to mechanical pinprick stimuli

  3. Change in intensity of perception to mechanical pinprick nociceptive stimuli [Change from Baseline, at 15-minutes after the end of stimulation]

    Numerical rating scale (0-100)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 NOCIONS lab Brussels Belgium 1200

Sponsors and Collaborators

  • Université Catholique de Louvain

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT05127200
Other Study ID Numbers:
  • 2021/02SEP/359
First Posted:
Nov 19, 2021
Last Update Posted:
Jun 10, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Université Catholique de Louvain
tsDCS
non-invasive neuromodulation
healthy volunteers
Additional relevant MeSH terms:
Nociceptive Pain

Study Results

No Results Posted as of Jun 10, 2022