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Analgesic Effect of Non Invasive Stimulation : Transcranial Direct Current Stimulation of Opercular-insular Cortex (STIM-INSULA)

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ClinicalTrials.gov Identifier: NCT03015558
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Neuropathic Pain 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. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (tDCS) for Neuropathic Chronic Pain : Study of the Opercular-insular Cortex Stimulation
Actual Study Start Date : November 2, 2016
Estimated Primary Completion Date : January 2, 2021
Estimated Study Completion Date : January 2, 2021

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.




Primary Outcome Measures :
  1. In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials with pain scale [ Time Frame: just before the tDCS session at Day 0 ]
  2. In patients : Changes in daily ratings of global pain [ Time Frame: just before the tDCS session at Day 0 ]
  3. In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials [ Time Frame: just after the tDCS session at Day 0 ]
  4. In patients : Changes in daily ratings of global pain [ Time Frame: just after the tDCS session at Day 0 ]
  5. In patients : Changes in daily ratings of global pain [ Time Frame: at week 1 ]

Secondary Outcome Measures :
  1. ongoing pain with pain scale [ Time Frame: just before the tDCS session at Day 0 ]
  2. ongoing pain with pain scale [ Time Frame: just after the tDCS session at Day 0 ]
  3. ongoing pain as assessed by daily ratings [ Time Frame: during one week ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015558


Contacts
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Contact: Luis GARCIA-LARREA, MD 4 72 11 88 66 ext +33 luis.garcia-larrea@univ-lyon1.fr
Contact: Nathalie ANDRE-OBADIA, MD 4 72 35 70 68 ext +33 nathalie.obadia-andre@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon - NeuroPain lab - CRNL Recruiting
Bron, France, 69500
Contact: Luis GARCIA-LARREA, MD    4 72 11 88 66 ext +33    luis.garcia-larrea@univ-lyon1.fr   
Contact: Nathalie ANDRE-OBADIA, MD    4 72 35 70 68 ext +33    nathalie.obadia-andre@chu-lyon.fr   
Principal Investigator: Luis GARCIA-LARREA, MD         
Sub-Investigator: Nathalie ANDRE-OBADIA, MD         
Sub-Investigator: Patrick Mertens, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Luis GARCIA-LARREA, MD NeuroPain lab - CRNL (Inserm U1028 - UCBL)
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03015558    
Other Study ID Numbers: 69HCL15_0345
2016-A00022-49 ( Other Identifier: ID-RCB )
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hospices Civils de Lyon:
Drug Resistance
Neuropathic Pain
opercular-insular cortex
Transcranial Direct Current Stimulation
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations