search
Back to results

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

Primary Purpose

Neuropathic Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
transcranial direct current stimulation of opercular-insular cortex - anodal active tDCS session
transcranial direct current stimulation of opercular-insular cortex - active control session
transcranial direct current stimulation of opercular-insular cortex - sham control session.
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring Drug Resistance, Neuropathic Pain, opercular-insular cortex, Transcranial Direct Current Stimulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospices Civils de Lyon - NeuroPain lab - CRNL

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

patients

healthy subjects

Arm Description

Outcomes

Primary Outcome Measures

In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials with pain scale
In patients : Changes in daily ratings of global pain
In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials
In patients : Changes in daily ratings of global pain
In patients : Changes in daily ratings of global pain

Secondary Outcome Measures

ongoing pain with pain scale
ongoing pain with pain scale
ongoing pain as assessed by daily ratings

Full Information

First Posted
December 22, 2016
Last Updated
December 6, 2021
Sponsor
Hospices Civils de Lyon
search

1. Study Identification

Unique Protocol Identification Number
NCT03015558
Brief Title
Analgesic Effect of Non Invasive Stimulation : Transcranial Direct Current Stimulation of Opercular-insular Cortex
Acronym
STIM-INSULA
Official Title
Transcranial Direct Current Stimulation (tDCS) for Neuropathic Chronic Pain : Study of the Opercular-insular Cortex Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 2, 2016 (Actual)
Primary Completion Date
March 28, 2018 (Actual)
Study Completion Date
March 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
Drug Resistance, Neuropathic Pain, opercular-insular cortex, Transcranial Direct Current Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients
Arm Type
Experimental
Arm Title
healthy subjects
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation of opercular-insular cortex - anodal active tDCS session
Intervention Description
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
Intervention Name(s)
transcranial direct current stimulation of opercular-insular cortex - active control session
Intervention Description
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
Intervention Name(s)
transcranial direct current stimulation of opercular-insular cortex - sham control session.
Intervention Description
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 Outcome Measure Information:
Title
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
Title
In patients : Changes in daily ratings of global pain
Time Frame
just before the tDCS session at Day 0
Title
In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials
Time Frame
just after the tDCS session at Day 0
Title
In patients : Changes in daily ratings of global pain
Time Frame
just after the tDCS session at Day 0
Title
In patients : Changes in daily ratings of global pain
Time Frame
at week 1
Secondary Outcome Measure Information:
Title
ongoing pain with pain scale
Time Frame
just before the tDCS session at Day 0
Title
ongoing pain with pain scale
Time Frame
just after the tDCS session at Day 0
Title
ongoing pain as assessed by daily ratings
Time Frame
during one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis GARCIA-LARREA, MD
Organizational Affiliation
NeuroPain lab - CRNL (Inserm U1028 - UCBL)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon - NeuroPain lab - CRNL
City
Bron
ZIP/Postal Code
69500
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs