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

Neuropathic Pain Clinical Trial

— STIM-INSULA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015558
• Other study ID #: 69HCL15_0345
• Secondary ID: 2016-A00022-49
• Status: Completed
• Phase: N/A
• Start date: November 2, 2016
• Est. completion date: March 28, 2018

Study information

• Verified date: December 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 28, 2018
• Est. primary completion date: March 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - NeuroPain lab - CRNL	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	In patients : Changes in daily ratings of global pain		just before the tDCS session at Day 0
Primary	In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials		just after the tDCS session at Day 0
Primary	In patients : Changes in daily ratings of global pain		just after the tDCS session at Day 0
Primary	In patients : Changes in daily ratings of global pain		at week 1
Secondary	ongoing pain with pain scale		just before the tDCS session at Day 0
Secondary	ongoing pain with pain scale		just after the tDCS session at Day 0
Secondary	ongoing pain as assessed by daily ratings		during one week