Analgesic Effect of Non Invasive Stimulation : Transcranial Direct Current Stimulation of Opercular-insular Cortex
- Conditions
- Neuropathic Pain
- Interventions
- 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.
- Registration Number
- NCT03015558
- Lead Sponsor
- Hospices Civils de Lyon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description patients transcranial direct current stimulation of opercular-insular cortex - anodal active tDCS session - healthy subjects transcranial direct current stimulation of opercular-insular cortex - anodal active tDCS session - healthy subjects transcranial direct current stimulation of opercular-insular cortex - active control session - healthy subjects transcranial direct current stimulation of opercular-insular cortex - sham control session. - patients transcranial direct current stimulation of opercular-insular cortex - active control session - patients transcranial direct current stimulation of opercular-insular cortex - sham control session. -
- Primary Outcome Measures
Name Time Method 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 at week 1 In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials just after the tDCS session at Day 0
- Secondary Outcome Measures
Name Time Method ongoing pain with pain scale just after the tDCS session at Day 0 ongoing pain as assessed by daily ratings during one week
Trial Locations
- Locations (1)
Hospices Civils de Lyon - NeuroPain lab - CRNL
🇫🇷Bron, France