NCT03015558

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2018

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

1.4 years

First QC Date

December 22, 2016

Last Update Submit

December 13, 2025

Conditions

Neuropathic Pain

Keywords

Drug ResistanceNeuropathic Painopercular-insular cortexTranscranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

patients

EXPERIMENTAL
Device: transcranial direct current stimulation of opercular-insular cortex - anodal active tDCS sessionDevice: transcranial direct current stimulation of opercular-insular cortex - active control sessionDevice: transcranial direct current stimulation of opercular-insular cortex - sham control session.

healthy subjects

ACTIVE COMPARATOR
Device: transcranial direct current stimulation of opercular-insular cortex - anodal active tDCS sessionDevice: transcranial direct current stimulation of opercular-insular cortex - active control sessionDevice: transcranial direct current stimulation of opercular-insular cortex - sham control session.

Interventions

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

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 subjectspatients
transcranial direct current stimulation of opercular-insular cortex - active control sessionDEVICE

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 subjectspatients
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.

healthy subjectspatients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon - NeuroPain lab - CRNL

Bron, 69500, France

Location

Related Publications (1)

  • 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.

    PMID: 31636023RESULT

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Luis GARCIA-LARREA, MD

    NeuroPain lab - CRNL (Inserm U1028 - UCBL)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2016

First Posted

January 10, 2017

Study Start

November 2, 2016

Primary Completion

March 28, 2018

Study Completion

March 28, 2018

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)