Neuropathic PainSTIM-INSULANCT03015558
Analgesic Effect of Non Invasive Stimulation : Transcranial Direct Current Stimulation of Opercular-insular Cortex
A study testing transcranial direct current stimulation of opercular-insular cortex - anodal active tDCS session in people with Neuropathic Pain, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- transcranial direct current stimulation of opercular-insular cortex - anodal active tDCS session
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2016to 28 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- ferromagnetic intracranial device
- implanted stimulator
- recent neurosurgery and open wound of the scalp.
- absence of contraceptive method for women of childbearing age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Direct Current Stimulation (tDCS) for Neuropathic Chronic Pain : Study of the Opercular-insular Cortex Stimulation
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.
- Conditions
- Neuropathic Pain
- Being tested
- transcranial direct current stimulation of opercular-insular cortex - anodal active tDCS session, transcranial direct current stimulation of opercular-insular cortex - active control session, transcranial direct current stimulation of opercular-insular cortex - sham control session.
- Keywords
- Drug Resistance, Neuropathic Pain, opercular-insular cortex, Transcranial Direct Current Stimulation
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation of opercular-insular cortex - anodal active tDCS sessionDevice
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 - active control sessionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | Not described Receives: 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. |
| healthy subjects | Active comparator | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials with pain scale
Measured: just before the tDCS session at Day 0
In patients : Changes in daily ratings of global pain
Measured: just before the tDCS session at Day 0
In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials
Measured: just after the tDCS session at Day 0
In patients : Changes in daily ratings of global pain
Measured: just after the tDCS session at Day 0
In patients : Changes in daily ratings of global pain
Measured: at week 1
Secondary outcomes (3)
ongoing pain with pain scale
Measured: just before the tDCS session at Day 0
ongoing pain with pain scale
Measured: just after the tDCS session at Day 0
ongoing pain as assessed by daily ratings
Measured: during one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start2 Nov 2016
- Primary completion28 Mar 2018
- Study completion28 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis GARCIA-LARREA, MD, Principal investigator, NeuroPain lab - CRNL (Inserm U1028 - UCBL)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015558
- Sponsor's protocol ID
- 69HCL15_0345
- Other IDs
- 2016-A00022-49
- Acronym
- STIM-INSULA
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2016
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31636023
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) for Neuropathic Chronic Pain : Study of the Opercular-insular Cortex Stimulation
- ClinicalTrials.gov ID
- NCT03015558
- Acronym / sponsor ID
- STIM-INSULA / 69HCL15_0345
- Conditions
- Neuropathic Pain
- Keywords
- Drug Resistance, Neuropathic Pain, opercular-insular cortex, Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Nov 2016 (actual)
- Primary completion
- 28 Mar 2018 (actual)
- Study completion
- 28 Mar 2018 (actual)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | 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. |
| healthy subjects | Active comparator | 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- history of chronic pain
- analgesic medication within 24h before stimulation
- For patients only: new analgesic treatment within 1 month before consent
- drug addiction, headache, epilepsy
- ferromagnetic intracranial device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulation of opercular-insular cortex - anodal active tDCS sessiontranscranial 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 | healthy subjects, patients |
| transcranial direct current stimulation of opercular-insular cortex - active control sessiontranscranial 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 | healthy subjects, patients |
| 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. | Device | healthy subjects, patients |
Primary outcome
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
In patients : Changes in daily ratings of global pain
Time frame: just before the tDCS session at Day 0
In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials
Time frame: just after the tDCS session at Day 0
In patients : Changes in daily ratings of global pain
Time frame: just after the tDCS session at Day 0
In patients : Changes in daily ratings of global pain
Time frame: at week 1
3 secondary outcomes
ongoing pain with pain scale
Time frame: just before the tDCS session at Day 0
ongoing pain with pain scale
Time frame: just after the tDCS session at Day 0
ongoing pain as assessed by daily ratings
Time frame: during one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 31636023Hagiwara 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis GARCIA-LARREA, MD principal investigator
NeuroPain lab - CRNL (Inserm U1028 - UCBL)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation of opercular-insular cortex - anodal active tDCS session in people with Neuropathic Pain, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03015558, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.