Cervical Neuromodulation and Nociceptive Processing

NCT ID: NCT05127200

Last Updated: 2023-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-24

Study Completion Date

2022-12-05

Brief Summary

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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

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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.

Conditions

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Nociceptive Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Anodal tsDCS (cervical active, lumbar sham)

Participants will receive:

1. 20 minutes of 2.5 milliampere (mA) anodal tsDCS at the cervical level.
2. sham tsDCS at the lumbar level.

Group Type EXPERIMENTAL

Starstim (Neuroelectrics)

Intervention Type DEVICE

Anodal transcutaneous spinal direct current stimulation (a-tsDCS)

Anodal tsDCS (cervical sham, lumbar active)

Participants will receive:

1. 20 minutes of 2.5 milliampere (mA) anodal tsDCS at the lumbar level.
2. sham tsDCS at the cervical level.

Group Type ACTIVE_COMPARATOR

Starstim (Neuroelectrics)

Intervention Type DEVICE

Anodal transcutaneous spinal direct current stimulation (a-tsDCS)

Interventions

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Starstim (Neuroelectrics)

Anodal transcutaneous spinal direct current stimulation (a-tsDCS)

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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André Mouraux, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Université Catholique de Louvain

Locations

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NOCIONS lab

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 30321585 (View on PubMed)

Other Identifiers

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2021/02SEP/359

Identifier Type: -

Identifier Source: org_study_id

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