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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A00022-49 | Other Identifier | ID-RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients | Experimental |
| |
| healthy subjects | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation of opercular-insular cortex - anodal active tDCS 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
In healthy subjects only:
For patients only: new analgesic treatment within 1 month before consent
for both:
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| Name | Affiliation | Role |
|---|---|---|
| Luis GARCIA-LARREA, MD | NeuroPain lab - CRNL (Inserm U1028 - UCBL) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon - NeuroPain lab - CRNL | Bron | 69500 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31636023 | Result | 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. |
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|
| transcranial direct current stimulation of opercular-insular cortex - active 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. |
|
| 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. |
|
| during one week |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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