Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-26 @ 10:34 PM
Study NCT ID:
NCT01261650
Status:
TERMINATED
Last Update Posted:
2014-07-03
First Post:
2010-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Transcranial Direct Current Stimulation of the Primary Motor Cortex on Pain Sensation in Patients Suffering From Fibromyalgia Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic 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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'whyStopped': 'There could not be enough patients recruited', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-02', 'studyFirstSubmitDate': '2010-12-14', 'studyFirstSubmitQcDate': '2010-12-15', 'lastUpdatePostDateStruct': {'date': '2014-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analoge Scale', 'timeFrame': 'Difference Baseline - after treatment'}], 'secondaryOutcomes': [{'measure': 'Quality of Life - SF-36', 'timeFrame': 'baseline / after treatment / 1 , 2, 3 months after treatment'}, {'measure': 'Fibromyalgia Impact Questionaire', 'timeFrame': 'baseline / after treatment / 1,2,3, months after treatment'}, {'measure': 'IL-10 ELISA', 'timeFrame': 'baseline / after treatment / 1,2,3, months after treatment'}, {'measure': 'Visual analog scale', 'timeFrame': '1,2,3 months after treatment'}, {'measure': 'IL-6 ELISA', 'timeFrame': 'baseline / after treatment / 1,2,3, months after treatment'}, {'measure': 'IL-4 ELISA', 'timeFrame': 'baseline / after treatment / 1,2,3, months after treatment'}, {'measure': 'TNF-alpha ELISA', 'timeFrame': 'baseline / after treatment / 1,2,3, months after treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['widespread chronic pain, transcranial direct current stimulation, fibromyalgia'], 'conditions': ['Fibromyalgia']}, 'descriptionModule': {'briefSummary': 'Fibromyalgia is a common chronic pain syndrome characterized by bad treatable chronic widespread pain present at a similar level for at least 3 months. The aim of this study is to examine if 3 weeks of transcranial direct current stimulation is a suitable therapy to reduce chronic pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have an established diagnosis of fibromyalgia according to the 1990 criteria of the "American College of Rheumatology"\n* Symptoms have been present at a similar level for at least 3 months\n* Stable medication for at least 2 months\n* visual analog scale ≥ 3 (0=no pain; 10=worst possible pain)\n* The patient does not have a disorder that would otherwise explain the pain\n\nExclusion Criteria:\n\n* Alcohol/substance abuse\n* Pregnancy\n* Neuropsychiatric disorders\n* Metal implants near stimulation area\n* Cardiac pace maker\n* Local injuries\n* Inflammatory rheumatic disease\n* Acute tumor\n* Acute fracture\n* Well-defined neuropathic induced pain'}, 'identificationModule': {'nctId': 'NCT01261650', 'briefTitle': 'Influence of Transcranial Direct Current Stimulation of the Primary Motor Cortex on Pain Sensation in Patients Suffering From Fibromyalgia Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Karl Landsteiner Institute of Remobilization and Functional Health'}, 'officialTitle': 'Influence of Transcranial Direct Current Stimulation of the Primary Motor Cortex on Pain Sensation in Patients Suffering From Fibromyalgia Syndrome', 'orgStudyIdInfo': {'id': 'FIBRO 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'transcranial direct current stimulation', 'description': 'transcranial direct current stimulation of the primary motor cortex', 'interventionNames': ['Device: transcranial direct current stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham treatment', 'interventionNames': ['Device: sham treatment']}], 'interventions': [{'name': 'transcranial direct current stimulation', 'type': 'DEVICE', 'armGroupLabels': ['transcranial direct current stimulation']}, {'name': 'sham treatment', 'type': 'DEVICE', 'armGroupLabels': ['sham treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1100', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Karl Landsteiner Institute of Remobilisation and Functional Health', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Michael Quittan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karl Landsteiner Institute of Remobilisation and functional Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karl Landsteiner Institute of Remobilization and Functional Health', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Karl Landsteiner Institute of Remobilization and Functional Health', 'oldOrganization': 'Institute of Physical Medicine and Rehabilitation'}}}}