Neuropathic Pain
Conditions
Keywords
Drug Resistance, Neuropathic Pain, opercular-insular cortex, Transcranial Direct Current Stimulation
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.
Interventions
DEVICEtranscranial 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.
DEVICEtranscranial 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.
DEVICEtranscranial 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.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| ongoing pain with pain scale | just before the tDCS session at Day 0 |
| ongoing pain as assessed by daily ratings | during one week |
Countries
France
Outcome results
None listed