Clinical trial NCT03015558: Analgesic Effect of Non Invasive Stimulation : Transcranial Direct Current Stimulation of Opercular-insular Cortex
Official title: Transcranial Direct Current Stimulation (tDCS) for Neuropathic Chronic Pain : Study of the Opercular-insular Cortex Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Keywords: Drug Resistance
Neuropathic Pain
opercular-insular cortex
Transcranial Direct Current Stimulation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials with pain scale
timeFrame: just before the tDCS session at Day 0
measure: In patients : Changes in daily ratings of global pain
timeFrame: just before the tDCS session at Day 0
measure: In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials
timeFrame: just after the tDCS session at Day 0
measure: In patients : Changes in daily ratings of global pain
timeFrame: just after the tDCS session at Day 0
measure: In patients : Changes in daily ratings of global pain
timeFrame: at week 1
Secondary outcomes:
measure: ongoing pain with pain scale
timeFrame: just before the tDCS session at Day 0
measure: ongoing pain with pain scale
timeFrame: just after the tDCS session at Day 0
measure: ongoing pain as assessed by daily ratings
timeFrame: during one week
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon - NeuroPain lab - CRNL
Study officials:
affiliation: NeuroPain lab - CRNL (Inserm U1028 - UCBL)
name: Luis GARCIA-LARREA, MD
role: PRINCIPAL_INVESTIGATOR
References: