Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 9:54 PM
Study NCT ID:
NCT07361692
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-26
First Post:
2026-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Transcranial Direct Current Stimulation (tDCS) in the Management of Complex Regional Pain Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020918', 'term': 'Complex Regional Pain Syndromes'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-23', 'studyFirstSubmitDate': '2026-01-15', 'studyFirstSubmitQcDate': '2026-01-15', 'lastUpdatePostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analog Visual Scale', 'timeFrame': 'one month post treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transcranial direct current stimulation', 'Complex Regional Pain Syndrome', 'pain', 'quality of life', 'anxiety', 'central sensitization'], 'conditions': ['Complex Regional Pain Syndrome (CRPS)']}, 'descriptionModule': {'briefSummary': 'Transcranial direct current stimulation (tDCS) is a non-invasive therapy increasingly used in facilities treating patients with chronic pain. This complementary therapy has the advantage of being non-pharmacological, with transient and mild side effects, an excellent safety profile, and good efficacy in the contexts where it has been the subject of dedicated research: neuropathic pain, fibromyalgia, and visceral pain. Few studies have focused on the application of tDCS in the context of complex regional pain syndrome (CRPS), which is a common condition.', 'detailedDescription': 'This protocol aims to compare a group receiving a tDCS protocol with a sham control group. The hypothesis of this study is that tDCS is effective in treating CRPS in terms of reducing pain and the functional and emotional consequences of pain.\n\nThe primary objective of the study is to evaluate the effectiveness of tDCS on pain in patients with CRPS (complex regional pain syndrome), measured by the numerical pain scale (EN), after one month of treatment and one month after the end of treatment, compared to the sham arm.\n\nThe secondary objectives are:\n\n* To assess anxiety and depression symptoms (HAD)\n* To assess the functional impact of pain (Concise Pain Questionnaire - QCD)\n* To assess central sensitization (Central Sensitization Inventory - CSI)\n* To identify adverse effects related to tDCS'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major\n* Clinically active or active complex regional pain syndrome (CRPS) with positive Budapest criteria\n* Scintigraphy showing signs consistent with CRPS\n* Being affiliated with or a beneficiary of a social security scheme\n\nExclusion Criteria:\n\n* Algodystrophy no longer meeting the Budapest criteria\n* Relative contraindication to tDCS: psychosis (including treated psychosis), uncontrolled epilepsy, large scalp scar, intracerebral/intracranial metallic body\n* Pregnant or breastfeeding women\n* Minors\n* Persons under legal protection (guardianship, conservatorship, and protective supervision)\n* Persons deprived of their liberty by judicial or administrative order\n* Unwilling individuals who cannot give their consent or cannot return for scheduled visits according to the protocol'}, 'identificationModule': {'nctId': 'NCT07361692', 'acronym': 'ALGOSTIM', 'briefTitle': 'Effectiveness of Transcranial Direct Current Stimulation (tDCS) in the Management of Complex Regional Pain Syndrome', 'organization': {'class': 'OTHER', 'fullName': "Polyclinique de l'Europe"}, 'officialTitle': 'Study of the Effectiveness of Transcranial Direct Current Stimulation (tDCS) in the Management of Complex Regional Pain Syndrome', 'orgStudyIdInfo': {'id': '2025-20-ESN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient group receiving tDCS stimulation', 'description': 'Progressive increase in stimulation intensity up to 2 mA, then continuation at a plateau for a total of 20 minutes, then a decrease in stimulation intensity for 30 seconds at the end of the session before an automatic stop.', 'interventionNames': ['Other: transcranial direct current stimulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Patient group receiving tDCS placebo stimulation', 'description': 'Control group : The stimulation intensity is gradually increased up to 2 mA for 1 minute, then decreased to zero stimulation. A further increase in stimulation is programmed 10 minutes after the start of stimulation.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'transcranial direct current stimulation', 'type': 'OTHER', 'description': 'progressive increase in stimulation intensity up to 2 mA, then continuation at a plateau for a total of 20 minutes, then a decrease in stimulation intensity for 30 seconds at the end of the session before an automatic stop.', 'armGroupLabels': ['Patient group receiving tDCS stimulation']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'The stimulation intensity is gradually increased up to 2 mA for 1 minute, then decreased to zero stimulation. A further increase in stimulation is programmed 10 minutes after the start of stimulation.', 'armGroupLabels': ['Patient group receiving tDCS placebo stimulation']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Polyclinique de l'Europe", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}