Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2026-02-23 @ 6:29 AM
Study NCT ID:
NCT02747758
Status:
TERMINATED
Last Update Posted:
2023-03-16
First Post:
2016-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Direct Current Stimulation (tDCS) in Chronic Neuropathy
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'}]}, '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'Recruitment due to CORONA', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-14', 'studyFirstSubmitDate': '2016-04-15', 'studyFirstSubmitQcDate': '2016-04-19', 'lastUpdatePostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'relative pain intensity', 'timeFrame': 'after completion of therapy series, typically after 2 weeks of treatment', 'description': 'relative reduction in pain intensity (initial VAS measured versus VAS after completion of the therapy series), VAS as a numeric value between 0 and 10.'}], 'secondaryOutcomes': [{'measure': 'acute pain reduction by tDCS application (relative reduciton measured as VAS after completion of tDCS stimulation versus initial VAS measured before stimulation)', 'timeFrame': '30 Minutes after application', 'description': 'relative reduction of pain intensity before and after each tDCS session and infiltration'}, {'measure': 'time to next regional-anesthesiological series', 'timeFrame': '6 months', 'description': 'time until patients need additional regional-anesthesiological interventions'}, {'measure': 'number of regional-anesthesiological interventions for pain control', 'timeFrame': '10 days', 'description': 'number of required regional-anesthesiological interventions to achieve sufficient pain reduction'}, {'measure': 'adverse events', 'timeFrame': '1 months', 'description': 'Analysis of adverse reaction (skin redness, headache, concentration, other)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['neuropathic pain', 'neuralgia', 'tDCS', 'transcranial direct current stimulation'], 'conditions': ['Neuropathic Pain', 'Neuralgia']}, 'referencesModule': {'availIpds': [{'url': 'https://www.frontiersin.org/articles/10.3389/fneur.2023.1069434/full', 'type': 'Clinical Study Report', 'comment': 'The research report is published open access:\n\nORIGINAL RESEARCH article Front. Neurol., 01 March 2023, Volume 14 - 2023 \\| https://doi.org/10.3389/fneur.2023.1069434'}], 'references': [{'pmid': '25479710', 'type': 'BACKGROUND', 'citation': 'Tafelski S, Beutlhauser T, Gouliou-Mayerhauser E, Fritzsche T, Denke C, Schafer M. [Practice of regional anesthesia for chronic pain patients in specialized pain services : A nationwide survey in Germany]. Schmerz. 2015 Apr;29(2):186-94. doi: 10.1007/s00482-014-1503-6. German.'}, {'pmid': '17053811', 'type': 'BACKGROUND', 'citation': 'Flor H, Nikolajsen L, Staehelin Jensen T. Phantom limb pain: a case of maladaptive CNS plasticity? Nat Rev Neurosci. 2006 Nov;7(11):873-81. doi: 10.1038/nrn1991.'}, {'pmid': '23321703', 'type': 'BACKGROUND', 'citation': 'Hauser W, Schmutzer G, Hinz A, Hilbert A, Brahler E. [Prevalence of chronic pain in Germany. A representative survey of the general population]. Schmerz. 2013 Feb;27(1):46-55. doi: 10.1007/s00482-012-1280-z. German.'}, {'pmid': '20471549', 'type': 'BACKGROUND', 'citation': 'Antal A, Terney D, Kuhnl S, Paulus W. Anodal transcranial direct current stimulation of the motor cortex ameliorates chronic pain and reduces short intracortical inhibition. J Pain Symptom Manage. 2010 May;39(5):890-903. doi: 10.1016/j.jpainsymman.2009.09.023.'}, {'pmid': '26469395', 'type': 'BACKGROUND', 'citation': 'Volz MS, Farmer A, Siegmund B. Reduction of chronic abdominal pain in patients with inflammatory bowel disease through transcranial direct current stimulation: a randomized controlled trial. Pain. 2016 Feb;157(2):429-437. doi: 10.1097/j.pain.0000000000000386.'}], 'seeAlsoLinks': [{'url': 'https://anaesthesieintensivmedizin.charite.de/leistungen/schmerztherapie/', 'label': 'Pain Clinic Website'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of additional transcranial direct stimulation (tDCS) on pain in patients with chronic neuropathic pain undergoing treatment with regional anaesthesiological techniques.', 'detailedDescription': 'About 3.8 Million persons in Germany suffer from chronic pain with a relevant physical and social impairment representing approximately 7% of the population. Chronic pain conditions include patients with neuropathic pain such as trigeminal neuralgia, post-zoster pain or pain after amputations. There is a significant number of patients with pain without response to optimised drug therapy. Especially in these chronic pain patients there is data demonstrating maladaptive plasticity as pathophysiological evidence of structural changes in brain connectivity. Patients are treated with multimodal pain therapy concepts including interventional procedures with nerve infiltration techniques.\n\nOne innovative therapeutic option for pain patients is transcranial direct current stimulation (tDCS): In recent clinical trials, patients reported on reduced overall pain intensity following tDCS stimulation series shown e.g. from Bolognini et al., Antal et al. and most recently from Volz and colleagues. However, there is no current data available evaluating a role of tDCS for patients with chronic neuropathic pain treated with regional anaesthesiological techniques.\n\nObjective: To evaluate effect of additional tDCS series on pain in patients with chronic neuropathic pain\n\nPrimary study endpoint: relative reduction in pain (initial VAS measured versus VAS after completion of the therapy series) as a numeric value between 0 and 10.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with neuropathic pain with indication of regional anaesthesiological interventions\n\nExclusion Criteria:\n\n* \\<18 years of age\n* Pregnancy\n* Police custody\n* Epilepsy\n* Participation in another prospective clinical intervention study within the last 30 days'}, 'identificationModule': {'nctId': 'NCT02747758', 'acronym': 'Neuro-tDCS', 'briefTitle': 'Transcranial Direct Current Stimulation (tDCS) in Chronic Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Randomized Controlled Clinical Trial Evaluating Transcranial Direct Current Stimulation (tDCS) in Chronic Pain Patients With Neuropathy', 'orgStudyIdInfo': {'id': 'Neuro-tDCS1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'sham transcranial direct current stimulation (tDCS)', 'interventionNames': ['Device: sham transcranial direct current stimulation (tDCS)']}, {'type': 'EXPERIMENTAL', 'label': 'cathodal stimulation', 'description': 'cathodal transcranial direct current stimulation (tDCS)', 'interventionNames': ['Device: cathodal transcranial direct current stimulation (tDCS)']}, {'type': 'EXPERIMENTAL', 'label': 'anodal stimulation', 'description': 'anodal transcranial direct current stimulation (tDCS)', 'interventionNames': ['Device: anodal transcranial direct current stimulation (tDCS)']}], 'interventions': [{'name': 'cathodal transcranial direct current stimulation (tDCS)', 'type': 'DEVICE', 'description': 'transcranial direct current stimulation (tDCS) is applied in active groups using cathodal active M1 stimulation. Active stimulation is applied with 2mA direct current via 20cm² electrodes.', 'armGroupLabels': ['cathodal stimulation']}, {'name': 'sham transcranial direct current stimulation (tDCS)', 'type': 'DEVICE', 'description': 'transcranial direct current stimulation (tDCS) is applied in active groups using a sham-stimulation including ramp up and ramp down of current.', 'armGroupLabels': ['Control']}, {'name': 'anodal transcranial direct current stimulation (tDCS)', 'type': 'DEVICE', 'description': 'transcranial direct current stimulation (tDCS) is applied in active groups using anodal active M1 stimulation. Active stimulation is applied with 2mA direct current via 20cm² electrodes.', 'armGroupLabels': ['anodal stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Pain Clinic of Charité hospital Campus Virchow Klinikum', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Michael Schäfer, Prof. MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Charité University Berlin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'physician scientist', 'investigatorFullName': 'Sascha Tafelski', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}