Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2025-12-26 @ 3:27 AM
Study NCT ID:
NCT00928720
Status:
COMPLETED
Last Update Posted:
2018-07-03
First Post:
2009-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D003863', 'term': 'Depression'}], '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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'agt@virginia.edu', 'phone': '434-924-0113', 'title': 'Ann Gill Taylor, Professor Nursing', 'organization': 'University of Virginia School of Nursing'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'CES Device', 'description': 'cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.', 'otherNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Device', 'description': 'Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.\n\nsham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device.', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Usual Care Alone', 'description': 'No intervention; participants will receive usual medical care for fibromyalgia', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Intensity Using Numeric Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CES Device', 'description': 'cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.'}, {'id': 'OG001', 'title': 'Sham Device', 'description': 'Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.\n\nsham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device.'}, {'id': 'OG002', 'title': 'Usual Care Alone', 'description': 'No intervention; participants will receive usual medical care for fibromyalgia'}], 'classes': [{'categories': [{'measurements': [{'value': '5.12', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '6.36', 'spread': '2.11', 'groupId': 'OG001'}, {'value': '6.62', 'spread': '1.94', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.045', 'groupIds': ['OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'week 8', 'description': 'A Numeric Rating Scale ranging from 0 (no pain) to 10 (worst pain imaginable) to capture present pain intensity', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Fatigue Using Lee's Fatigue Scale", 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CES Device', 'description': 'Participants will use the device for 60 minutes each day for 8 weeks.\n\nCES device: Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.'}, {'id': 'OG001', 'title': 'Sham Device', 'description': 'Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.\n\nsham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device.'}, {'id': 'OG002', 'title': 'Usual Care Alone', 'description': 'No intervention; participants will receive usual medical care'}], 'classes': [{'categories': [{'measurements': [{'value': '4.97', 'spread': '2.45', 'groupId': 'OG000'}, {'value': '6.38', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '6.83', 'spread': '2.35', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': "A Numeric Rating Scale ranging from 0-10 to capture present levels of fatigue using the fatigue subscale of Lee's Fatigue Scale", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'General Sleep Disturbance Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CES Device', 'description': 'cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.'}, {'id': 'OG001', 'title': 'Sham Device', 'description': 'Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.\n\nsham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device.'}, {'id': 'OG002', 'title': 'Usual Care Alone', 'description': 'No intervention; usual medical care for fibromyalgia'}], 'classes': [{'categories': [{'measurements': [{'value': '2.79', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '3.86', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '3.53', 'spread': '1.14', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Depression Using the CES-D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CES Device', 'description': 'cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.'}, {'id': 'OG001', 'title': 'Sham Device', 'description': 'Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.\n\nsham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device.'}, {'id': 'OG002', 'title': 'Usual Care Alone', 'description': 'No intervention; usual medical care for fibromyalgia'}], 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '28.63', 'spread': '14.9', 'groupId': 'OG001'}, {'value': '23.42', 'spread': '13.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Perceived Stress Using Numeric Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CES Device', 'description': 'cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.'}, {'id': 'OG001', 'title': 'Sham Device', 'description': 'Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.\n\nsham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device.'}, {'id': 'OG002', 'title': 'Usual Care Alone', 'description': 'No intervention; usual medical care for fibromyalgia'}], 'classes': [{'categories': [{'measurements': [{'value': '3.93', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '5.64', 'spread': '2.66', 'groupId': 'OG001'}, {'value': '5.29', 'spread': '2.61', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Functional Status Using the Fibromyalgia Index Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CES Device', 'description': 'cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.'}, {'id': 'OG001', 'title': 'Sham Device', 'description': 'Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.\n\nsham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device.'}, {'id': 'OG002', 'title': 'Usual Care Alone', 'description': 'No intervention; usual medical care for fibromyalgia'}], 'classes': [{'categories': [{'measurements': [{'value': '45.05', 'spread': '16.3', 'groupId': 'OG000'}, {'value': '70.1', 'spread': '22.3', 'groupId': 'OG001'}, {'value': '63.2', 'spread': '19.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CES Device', 'description': 'cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.'}, {'id': 'FG001', 'title': 'Sham Device', 'description': 'Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.\n\nsham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device.'}, {'id': 'FG002', 'title': 'Usual Care Alone', 'description': 'No intervention; usual medical care for fibromyalgia'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'CES Device', 'description': 'cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.'}, {'id': 'BG001', 'title': 'Sham Device', 'description': 'Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.\n\nsham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device.'}, {'id': 'BG002', 'title': 'Usual Care Alone', 'description': 'No intervention; participants will received usual medical care for fibromyalgia'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.9', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '51.5', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '48.6', 'spread': '9.8', 'groupId': 'BG002'}, {'value': '50.8', 'spread': '10.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pain Numeric Rating Scale', 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '5.7', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '6.0', 'spread': '2.1', 'groupId': 'BG002'}, {'value': '5.8', 'spread': '1.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'A Numeric Rating Scale to capture average pain. The scales ranges from 0 (no pain) to 10 (worst pain imaginable).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fatigue', 'classes': [{'categories': [{'measurements': [{'value': '6.12', 'spread': '1.89', 'groupId': 'BG000'}, {'value': '6.66', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '6.85', 'spread': '1.74', 'groupId': 'BG002'}, {'value': '6.53', 'spread': '1.89', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'A Numeric Rating Scale to capture present fatigue. The scales ranges from 0 (no fatigue) to 10 (worst fatigue imaginable).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fibromyalgia impact', 'classes': [{'categories': [{'measurements': [{'value': '61.36', 'spread': '18.2', 'groupId': 'BG000'}, {'value': '65.98', 'spread': '17.9', 'groupId': 'BG001'}, {'value': '66.31', 'spread': '16.9', 'groupId': 'BG002'}, {'value': '64.51', 'spread': '17.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Fibromyalgia Impact Questionnaire is a brief assessment and evaluation instrument consisting of 19 items to measure patient status, progress, and outcomes of patients with fibromyalgia over the past week. The measure is self-administered and takes approximately 5 minutes to complete. Total scores range from 0 to 80, with 0 indicating no impact and 80 indicating maximum impact, thus a higher score indicating more negative impact.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Depression', 'classes': [{'categories': [{'measurements': [{'value': '23.9', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '29.5', 'spread': '13.7', 'groupId': 'BG001'}, {'value': '24.1', 'spread': '14.2', 'groupId': 'BG002'}, {'value': '26.0', 'spread': '13.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Center for Epidemiological Studies-Depression (CES-D) scale is a 20-item measure that asks the individual to rate how often over the past week s/he has experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item. Scores range from 0 to 60, with high scores indicating greater depressive symptoms. The CES-D also provides cutoff scores (e.g., 16 or greater) that aid in identifying individuals at risk for clinical depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'General sleep disturbance', 'classes': [{'categories': [{'measurements': [{'value': '3.75', 'spread': '0.94', 'groupId': 'BG000'}, {'value': '4.01', 'spread': '0.80', 'groupId': 'BG001'}, {'value': '3.6', 'spread': '0.86', 'groupId': 'BG002'}, {'value': '3.8', 'spread': '0.87', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The General Sleep Disturbance Scale (GSDS) is a subjective measure of sleep disturbance that contains 21 items rating the frequency of specific sleep problems during the past week from 0 to 7. Each item is rated on a numeric rating scale ranging from 0 to 7 and the total 21 items are summed to calculate total score ranging from 0 (no disturbance) to 147 (extreme disturbance); higher scores indicate greater sleep disturbances.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Daily stress impact', 'classes': [{'categories': [{'measurements': [{'value': '3.86', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '3.05', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '3.39', 'spread': '1.3', 'groupId': 'BG002'}, {'value': '3.44', 'spread': '1.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "The Daily Stress Inventory is a 58-item measure designed to quantify individuals' perceived daily stress by rating the stressfulness of the events identified on a Likert-type scale from 1 to 7. Three daily scores are derived for each individual: (1) number of events that are scored as having occurred (Frequency), (2) sum of the total of the impact rating of these events (Summary, and (3) average impact rating of the events (the AIR, which is obtained by dividing the Summary score by the Frequency Score). Scores range from 1 to 58, with higher scores indicating higher levels of stress.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-05', 'studyFirstSubmitDate': '2009-06-24', 'resultsFirstSubmitDate': '2014-06-05', 'studyFirstSubmitQcDate': '2009-06-25', 'lastUpdatePostDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-08-11', 'studyFirstPostDateStruct': {'date': '2009-06-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity Using Numeric Rating Scale', 'timeFrame': 'week 8', 'description': 'A Numeric Rating Scale ranging from 0 (no pain) to 10 (worst pain imaginable) to capture present pain intensity'}], 'secondaryOutcomes': [{'measure': "Fatigue Using Lee's Fatigue Scale", 'timeFrame': 'Week 8', 'description': "A Numeric Rating Scale ranging from 0-10 to capture present levels of fatigue using the fatigue subscale of Lee's Fatigue Scale"}, {'measure': 'General Sleep Disturbance Scale', 'timeFrame': 'Week 8'}, {'measure': 'Depression Using the CES-D', 'timeFrame': 'Week 8'}, {'measure': 'Perceived Stress Using Numeric Rating Scale', 'timeFrame': 'Week 8'}, {'measure': 'Functional Status Using the Fibromyalgia Index Questionnaire', 'timeFrame': 'Week 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fibromyalgia', 'pain', 'sleep disturbance', 'fatigue', 'depression', 'functional magnetic resonance imaging'], 'conditions': ['Fibromyalgia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects of mild cranial electrical stimulation on pain, fatigue, sleep disturbances, perceived stress, blood pressure, and functional status in persons with fibromyalgia.', 'detailedDescription': 'Central pain networks in the brain are dysregulated in persons with fibromyalgia (FM). Thus, the investigators propose that cranial electrical stimulation (CES) that works on the brain may ameliorate symptoms of FM by interacting with the central pain networks. The specific aims of this randomized, controlled, three-group pilot study design are to: (1) determine differences in pain over time between the active CES, sham device, and usual care (UC) groups; (2) explore differences in brain activity in pain processing regions (i.e., cingulate, insula, prefrontal and somatosensory cortices, amygdala, and thalamus) between the active CES, sham device, and UC groups in a subset of 12 participants (6 in each device group); (3) determine the effects of CES on other symptoms (fatigue, sleep disturbances, depression, perceived stress) and functional status, and blood pressure over time between the active CES, sham device, and UC groups; and (4) determine the amount of influence that selected psychological factors (negative affect, catastrophizing, and other personality characteristics) have on group differences in pain, other symptoms, functional status, and brain activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* meet the diagnostic criteria for FM established by the American College of Rheumatology\n* have initial pain level equal to or greater than 3 on a NRS 0-10\n* have stable medication use related to FM for at least 4 weeks\n* be able to read, write, and understand the English language\n\nExclusion Criteria (all participants):\n\n* pregnant or breastfeeding\n* epilepsy or history of seizures\n* presence of pacemakers and/or other implanted devices\n\nExclusion Criteria (subset of 12 participants who wil have fMRIs):\n\n* conditions that would not permit an fMRI (e.g., certain types of metal or metallic objects in body, diaphragm or intrauterine device, dermal patches, ear or eye implants, implanted electrical stimulators, artificial heart valve, implanted catheter or tube, tattoos, claustrophobia; or weight more than 275 lbs)'}, 'identificationModule': {'nctId': 'NCT00928720', 'briefTitle': 'Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia', 'orgStudyIdInfo': {'id': '14203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CES device', 'description': 'Participants will use the device for 60 minutes each day for 8 weeks.', 'interventionNames': ['Device: CES device']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham device', 'description': 'Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.', 'interventionNames': ['Device: sham device']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care alone', 'description': 'No intervention; participants will receive usual medical care'}], 'interventions': [{'name': 'CES device', 'type': 'DEVICE', 'otherNames': ['Alpha-Stim'], 'description': 'Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.', 'armGroupLabels': ['CES device']}, {'name': 'sham device', 'type': 'DEVICE', 'description': 'The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device.', 'armGroupLabels': ['Sham device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Center for the Study of Complementary and Alternative Therapies', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Ann G Taylor, EdD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Nursing', 'investigatorFullName': 'Ann G Taylor', 'investigatorAffiliation': 'University of Virginia'}}}}