STIM-INSULA: Analgesic Effect of Non Invasive Stimulation : Transcranial Direct Current Stimulation of Opercular-insular Cortex
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: patients
|
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.
Device: 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.
Device: 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.
|
| Active Comparator: healthy subjects
|
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.
Device: 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.
Device: 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.
|
Outcome Measures
Primary Outcome Measures
- 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]
Secondary Outcome Measures
- 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 [during one week]
Eligibility Criteria
Criteria
Inclusion Criteria:
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healthy subjects aged from 18 to 70 years, male or female, with social security protection, fully informed and having given their written consent.
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patients aged from 18 to 80 years, male or female, with social security protection , fully informed and having given their written consent.
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pharmacoresistant neuropathic pain during at least one year,
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without any change of the pharmacological treatment since at least one month
Exclusion Criteria:
In healthy subjects only:
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history of chronic pain
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analgesic medication within 24h before stimulation
For patients only: new analgesic treatment within 1 month before consent
for both:
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drug addiction, headache, epilepsy
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ferromagnetic intracranial device
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implanted stimulator
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recent neurosurgery and open wound of the scalp.
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absence of contraceptive method for women of childbearing age
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospices Civils de Lyon - NeuroPain lab - CRNL | Bron | France | 69500 |
Sponsors and Collaborators
- Hospices Civils de Lyon
Investigators
- Principal Investigator: Luis GARCIA-LARREA, MD, NeuroPain lab - CRNL (Inserm U1028 - UCBL)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 69HCL15_0345
- 2016-A00022-49