Analgesic Effect of Non Invasive Stimulation : Transcranial Direct Current Stimulation of Opercular-insular Cortex (STIM-INSULA)

Transcranial Direct Current Stimulation (tDCS) for Neuropathic Chronic Pain : Study of the Opercular-insular Cortex Stimulation

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.

Study Overview

• Status: Completed
• Conditions: Neuropathic Pain
• Intervention / Treatment: Device: transcranial direct current stimulation of opercular-insular cortex - anodal active tDCS session; Device: transcranial direct current stimulation of opercular-insular cortex - active control session; Device: transcranial direct current stimulation of opercular-insular cortex - sham control session.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Hospices Civils de Lyon - NeuroPain lab - CRNL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients	Device: 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.; 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.; 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.
Active Comparator: healthy subjects	Device: 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.; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials with pain scale	just before the tDCS session at Day 0
In patients : Changes in daily ratings of global pain	just before the tDCS session at Day 0
In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials	just after the tDCS session at Day 0
In patients : Changes in daily ratings of global pain	just after the tDCS session at Day 0
In patients : Changes in daily ratings of global pain	at week 1

Secondary Outcome Measures

Outcome Measure	Time Frame
ongoing pain with pain scale	just before the tDCS session at Day 0
ongoing pain with pain scale	just after the tDCS session at Day 0
ongoing pain as assessed by daily ratings	during one week

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Luis GARCIA-LARREA, MD, NeuroPain lab - CRNL (Inserm U1028 - UCBL)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2016
• Primary Completion (Actual): March 28, 2018
• Study Completion (Actual): March 28, 2018

Study Registration Dates

• First Submitted: December 22, 2016
• First Submitted That Met QC Criteria: January 6, 2017
• First Posted (Estimated): January 10, 2017

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Transcranial Direct Current Stimulation; Neuropathic Pain; Drug Resistance; opercular-insular cortex
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neuralgia
• Other Study ID Numbers: 69HCL15_0345; 2016-A00022-49 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO