Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-02-03 @ 3:49 AM
Study NCT ID:
NCT03015558
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2016-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic Effect of Non Invasive Stimulation : Transcranial Direct Current Stimulation of Opercular-insular Cortex
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2018-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-13', 'studyFirstSubmitDate': '2016-12-22', 'studyFirstSubmitQcDate': '2017-01-06', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials with pain scale', 'timeFrame': 'just before the tDCS session at Day 0'}, {'measure': 'In patients : Changes in daily ratings of global pain', 'timeFrame': 'just before the tDCS session at Day 0'}, {'measure': 'In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials', 'timeFrame': 'just after the tDCS session at Day 0'}, {'measure': 'In patients : Changes in daily ratings of global pain', 'timeFrame': 'just after the tDCS session at Day 0'}, {'measure': 'In patients : Changes in daily ratings of global pain', 'timeFrame': 'at week 1'}], 'secondaryOutcomes': [{'measure': 'ongoing pain with pain scale', 'timeFrame': 'just before the tDCS session at Day 0'}, {'measure': 'ongoing pain with pain scale', 'timeFrame': 'just after the tDCS session at Day 0'}, {'measure': 'ongoing pain as assessed by daily ratings', 'timeFrame': 'during one week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug Resistance', 'Neuropathic Pain', 'opercular-insular cortex', 'Transcranial Direct Current Stimulation'], 'conditions': ['Neuropathic Pain']}, 'referencesModule': {'references': [{'pmid': '31636023', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy subjects aged from 18 to 70 years, male or female, with social security protection, fully informed and having given their written consent.\n* patients aged from 18 to 80 years, male or female, with social security protection , fully informed and having given their written consent.\n* pharmacoresistant neuropathic pain during at least one year,\n* without any change of the pharmacological treatment since at least one month\n\nExclusion Criteria:\n\nIn healthy subjects only:\n\n* history of chronic pain\n* analgesic medication within 24h before stimulation\n\nFor patients only: new analgesic treatment within 1 month before consent\n\nfor both:\n\n* drug addiction, headache, epilepsy\n* ferromagnetic intracranial device\n* implanted stimulator\n* recent neurosurgery and open wound of the scalp.\n* absence of contraceptive method for women of childbearing age'}, 'identificationModule': {'nctId': 'NCT03015558', 'acronym': 'STIM-INSULA', 'briefTitle': 'Analgesic Effect of Non Invasive Stimulation : Transcranial Direct Current Stimulation of Opercular-insular Cortex', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Transcranial Direct Current Stimulation (tDCS) for Neuropathic Chronic Pain : Study of the Opercular-insular Cortex Stimulation', 'orgStudyIdInfo': {'id': '69HCL15_0345'}, 'secondaryIdInfos': [{'id': '2016-A00022-49', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients', 'interventionNames': ['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.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'healthy subjects', 'interventionNames': ['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.']}], 'interventions': [{'name': 'transcranial direct current stimulation of opercular-insular cortex - anodal active tDCS session', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['healthy subjects', 'patients']}, {'name': 'transcranial direct current stimulation of opercular-insular cortex - active control session', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['healthy subjects', 'patients']}, {'name': 'transcranial direct current stimulation of opercular-insular cortex - sham control session.', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['healthy subjects', 'patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'country': 'France', 'facility': 'Hospices Civils de Lyon - NeuroPain lab - CRNL', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'overallOfficials': [{'name': 'Luis GARCIA-LARREA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NeuroPain lab - CRNL (Inserm U1028 - UCBL)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}