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Completed

NCT Number: NCT03015558

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

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.

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Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon - NeuroPain lab - CRNL

Bron, 69500, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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.

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.

Primary outcomes

  1. In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials with pain scale

    Time frame: just before the tDCS session at Day 0

  2. In patients : Changes in daily ratings of global pain

    Time frame: just before the tDCS session at Day 0

  3. In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials

    Time frame: just after the tDCS session at Day 0

  4. In patients : Changes in daily ratings of global pain

    Time frame: just after the tDCS session at Day 0

  5. In patients : Changes in daily ratings of global pain

    Time frame: at week 1

Secondary outcomes

  1. ongoing pain with pain scale

    Time frame: just before the tDCS session at Day 0

  2. ongoing pain with pain scale

    Time frame: just after the tDCS session at Day 0

  3. ongoing pain as assessed by daily ratings

    Time frame: during one week

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: STIM-INSULA

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 10, 2017
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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