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Analgesic Effect of Non Invasive Stimulation : Transcranial Direct Current Stimulation of Opercular-insular Cortex

Not Applicable
Completed
Conditions
Neuropathic Pain
Interventions
Device: transcranial direct current stimulation of opercular-insular cortex - anodal active tDCS session
Device: transcranial direct current stimulation of opercular-insular cortex - active control session
Device: 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
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
patientstranscranial direct current stimulation of opercular-insular cortex - anodal active tDCS session-
healthy subjectstranscranial direct current stimulation of opercular-insular cortex - anodal active tDCS session-
healthy subjectstranscranial direct current stimulation of opercular-insular cortex - active control session-
healthy subjectstranscranial direct current stimulation of opercular-insular cortex - sham control session.-
patientstranscranial direct current stimulation of opercular-insular cortex - active control session-
patientstranscranial direct current stimulation of opercular-insular cortex - sham control session.-
Primary Outcome Measures
NameTimeMethod
In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials with pain scalejust before the tDCS session at Day 0
In patients : Changes in daily ratings of global painat week 1
In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentialsjust after the tDCS session at Day 0
Secondary Outcome Measures
NameTimeMethod
ongoing pain with pain scalejust after the tDCS session at Day 0
ongoing pain as assessed by daily ratingsduring one week

Trial Locations

Locations (1)

Hospices Civils de Lyon - NeuroPain lab - CRNL

🇫🇷

Bron, France

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