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NCT03015558

Analgesic Effect of Non Invasive Stimulation : Transcranial Direct Current Stimulation of Opercular-insular Cortex

NCT ID: NCT03015558

Last Updated: 2025-12-19

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

2016-11-02

Study Completion Date

2018-03-28

Brief Summary

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The aim of this study is to evaluate, versus placebo, the analgesic efficacy of the opercular-insular cortex stimulation with Transcranial Direct Current Stimulation (tDCS), in both healthy subjects and chronic neuropathic pain patients. In healthy subjects analgesia by tDCS will be assessed using both laser stimuli and cold pressor test. In patients the assessment regards their chronic pain (ratings for ongoing, evoked and paroxysmal pain, sleep and fatigue). Opercular-insular stimulation is obtained via a combined 6-electrode montage and by bi-vestibular stimulation (since vestibular pathways reach the posterior insular cortex). In patients, three separate conditions (two active and one sham) will be tested in randomised order. In healthy subjects, two other conditions are added to control for attention and distraction confounders.

Detailed Description

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Conditions

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Neuropathic Pain

Keywords

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Drug Resistance Neuropathic Pain opercular-insular cortex Transcranial Direct Current Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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patients

Group Type EXPERIMENTAL

transcranial direct current stimulation of opercular-insular cortex - anodal active tDCS session

Intervention Type DEVICE

transcranial direct current stimulations of opercular-insular cortex. Three sessions separated by a minimum of 2 weeks, with three different conditions: one session with anodal active tDCS, one with active control, and one with sham control.

transcranial direct current stimulation of opercular-insular cortex - active control session

Intervention Type DEVICE

transcranial direct current stimulations of opercular-insular cortex. Three sessions separated by a minimum of 2 weeks, with three different conditions: one session with anodal active tDCS, one with active control, and one with sham control.

transcranial direct current stimulation of opercular-insular cortex - sham control session.

Intervention Type DEVICE

transcranial direct current stimulations of opercular-insular cortex. Three sessions separated by a minimum of 2 weeks, with three different conditions: one session with anodal active tDCS, one with active control, and one with sham control.

healthy subjects

Group Type ACTIVE_COMPARATOR

transcranial direct current stimulation of opercular-insular cortex - anodal active tDCS session

Intervention Type DEVICE

transcranial direct current stimulations of opercular-insular cortex. Three sessions separated by a minimum of 2 weeks, with three different conditions: one session with anodal active tDCS, one with active control, and one with sham control.

transcranial direct current stimulation of opercular-insular cortex - active control session

Intervention Type DEVICE

transcranial direct current stimulations of opercular-insular cortex. Three sessions separated by a minimum of 2 weeks, with three different conditions: one session with anodal active tDCS, one with active control, and one with sham control.

transcranial direct current stimulation of opercular-insular cortex - sham control session.

Intervention Type DEVICE

transcranial direct current stimulations of opercular-insular cortex. Three sessions separated by a minimum of 2 weeks, with three different conditions: one session with anodal active tDCS, one with active control, and one with sham control.

Interventions

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transcranial direct current stimulation of opercular-insular cortex - anodal active tDCS session

transcranial direct current stimulations of opercular-insular cortex. Three sessions separated by a minimum of 2 weeks, with three different conditions: one session with anodal active tDCS, one with active control, and one with sham control.

Intervention Type DEVICE

transcranial direct current stimulation of opercular-insular cortex - active control session

transcranial direct current stimulations of opercular-insular cortex. Three sessions separated by a minimum of 2 weeks, with three different conditions: one session with anodal active tDCS, one with active control, and one with sham control.

Intervention Type DEVICE

transcranial direct current stimulation of opercular-insular cortex - sham control session.

transcranial direct current stimulations of opercular-insular cortex. Three sessions separated by a minimum of 2 weeks, with three different conditions: one session with anodal active tDCS, one with active control, and one with sham control.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* healthy subjects aged from 18 to 70 years, male or female, with social security protection, fully informed and having given their written consent.
* patients aged from 18 to 80 years, male or female, with social security protection , fully informed and having given their written consent.
* pharmacoresistant neuropathic pain during at least one year,
* without any change of the pharmacological treatment since at least one month

Exclusion Criteria

In healthy subjects only:

* history of chronic pain
* analgesic medication within 24h before stimulation

For patients only: new analgesic treatment within 1 month before consent

for both:

* drug addiction, headache, epilepsy
* ferromagnetic intracranial device
* implanted stimulator
* recent neurosurgery and open wound of the scalp.
* absence of contraceptive method for women of childbearing age

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luis GARCIA-LARREA, MD

Role: PRINCIPAL_INVESTIGATOR

NeuroPain lab - CRNL (Inserm U1028 - UCBL)

Locations

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Hospices Civils de Lyon - NeuroPain lab - CRNL

Bron, , France

Site Status

Countries

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France

References

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Hagiwara K, Perchet C, Frot M, Bastuji H, Garcia-Larrea L. Cortical modulation of nociception by galvanic vestibular stimulation: A potential clinical tool? Brain Stimul. 2020 Jan-Feb;13(1):60-68. doi: 10.1016/j.brs.2019.10.009. Epub 2019 Oct 12.

Reference Type RESULT

PMID: 31636023 (View on PubMed)

Other Identifiers

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69HCL15_0345

Identifier Type: -

Identifier Source: org_study_id

2016-A00022-49

Identifier Type: OTHER

Identifier Source: secondary_id