Cervical/Thoracic Neuromodulation and Nociceptive Processing

NCT ID: NCT06367777

Last Updated: 2024-06-21

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

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-19

Study Completion Date

2024-10-31

Brief Summary

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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

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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.

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 cervical tsDCS

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.

Group Type EXPERIMENTAL

cervical a-tsDCS

Intervention Type DEVICE

Anodal transcutaneous spinal direct current stimulation (a-tsDCS)

Anodal thoracic tsDCS

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.

Group Type EXPERIMENTAL

thoracic a-tsDCS

Intervention Type DEVICE

Anodal transcutaneous spinal direct current stimulation (a-tsDCS)

Sham tsDCS

Participants will receive:

1. 20 minutes of sham tsDCS at the cervical level.
2. 20 minutes of sham tsDCS at the low-thoracic level.

Group Type SHAM_COMPARATOR

sham tsDCS

Intervention Type DEVICE

Sham transcutaneous spinal direct current stimulation (s-tsDCS)

Interventions

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cervical a-tsDCS

Anodal transcutaneous spinal direct current stimulation (a-tsDCS)

Intervention Type DEVICE

thoracic a-tsDCS

Anodal transcutaneous spinal direct current stimulation (a-tsDCS)

Intervention Type DEVICE

sham tsDCS

Sham transcutaneous spinal direct current stimulation (s-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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UCLouvain

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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André Mouraux, MD, PhD

Role: CONTACT

+3227645361

Arnaud Steyaert, MD

Role: CONTACT

+3227641821

Facility Contacts

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André Mouraux, PhD

Role: primary

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)

Related Links

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https://www.nocions.org

NOCIONS lab website

Other Identifiers

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2024/14MAR/132

Identifier Type: -

Identifier Source: org_study_id

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