Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2026-01-26 @ 11:31 AM
Study NCT ID:
NCT02633306
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2015-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transcranial Magnetic Stimulation for Facial Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061221', 'term': 'Trigeminal Nerve Injuries'}, {'id': 'D051474', 'term': 'Neuralgia, Postherpetic'}, {'id': 'D005157', 'term': 'Facial Pain'}, {'id': 'D002527', 'term': 'Myoclonic Cerebellar Dyssynergia'}], 'ancestors': [{'id': 'D020433', 'term': 'Trigeminal Nerve Diseases'}, {'id': 'D005156', 'term': 'Facial Neuralgia'}, {'id': 'D005155', 'term': 'Facial Nerve Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D020209', 'term': 'Cranial Nerve Injuries'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013132', 'term': 'Spinocerebellar Degenerations'}, {'id': 'D002526', 'term': 'Cerebellar Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shaines@umn.edu', 'phone': '612 624-6666', 'title': 'Stephen Haines, MD', 'organization': 'University of Minenesota'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Transcranial Magnetic Stimulation', 'description': 'transcranial magnetic stimulation\n\ntranscranial magnetic stimulation: Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Increased Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tremors', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-specific Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Analogue Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial Magnetic Stimulation', 'description': 'transcranial magnetic stimulation\n\ntranscranial magnetic stimulation: Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '11.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'groupDescription': 'In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.'}], 'paramType': 'MEAN', 'timeFrame': '7 days', 'description': 'Participants are asked to rate pain on a100 mm visual analogue scale with 0 representing no pain and 100 representing worst possible pain. The mean difference from baseline to 7 days post-treatment is recorded.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Three patients left the study before treatment. One of 6 patients who began treatment did not complete the full treatment regimen and therefore post treatment status could not be assessed.'}, {'type': 'SECONDARY', 'title': 'World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial Magnetic Stimulation', 'description': 'All patients enrolled 9 gave pretreatment data 6 gave 3 day post treatment data 5 gave 7 day post treatment data\n\n1 has missing data for 7 day post treatment social relationships score'}], 'classes': [{'title': 'pre-treatment baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '8'}]}]}, {'title': '3 days post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '8'}]}]}, {'title': '7 days post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '8'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'groupDescription': 'In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.'}], 'paramType': 'MEDIAN', 'timeFrame': 'pre-treatment, 3 and 7 days post treatment', 'description': 'A questionnaire used to determine the impact and burden of a disease on daily life. This assessment has 26 questions and covers the domains of physical and psychological health, social relationships, and environment. The answers to various question are included in one or more of the domains. Raw scores are transformed in several different ways by different investigators. We report raw scores. Domains have the following raw score ranges: Overall Quality of Life 2-10, Physical Heath 7-35, Psychological Health 6-30, Social Relationships 3-15, Environment 8-40, Total Raw Score 26-130. Higher scores in each of the domains correspond to greater perceived quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients for whom any data was acquired are included.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Young Mania Rating Scale (YMRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial Magnetic Stimulation', 'description': 'transcranial magnetic stimulation\n\ntranscranial magnetic stimulation: Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': '3 days post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': '7 days post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'groupDescription': 'In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.'}], 'paramType': 'MEDIAN', 'timeFrame': 'pre-treatment, 3 and 7 days post treatment', 'description': "The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours.\n\nThe YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'all enrolled patients'}, {'type': 'SECONDARY', 'title': 'World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Physical Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial Magnetic Stimulation', 'description': 'All patients enrolled 9 gave pretreatment data 6 gave 3 day post treatment data 5 gave 7 day post treatment data\n\n1 has missing data for 7 day post treatment social relationships score'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '28'}]}]}, {'title': '3 days post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '21'}]}]}, {'title': '7 days post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '19'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'groupDescription': 'In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.'}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, 3 and 7 days post treatment', 'description': 'A questionnaire used to determine the impact and burden of a disease on daily life. This assessment has 26 questions and covers the domains of physical and psychological health, social relationships, and environment. The answers to various question are included in one or more of the domains. Raw scores are transformed in several different ways by different investigators. We report raw scores. Domains have the following raw score ranges: Overall Quality of Life 2-10, Physical Heath 7-35, Psychological Health 6-30, Social Relationships 3-15, Environment 8-40, Total Raw Score 26-130. Higher scores in each of the domains correspond to greater perceived quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients'}, {'type': 'SECONDARY', 'title': 'World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Psychological Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial Magnetic Stimulation', 'description': 'All patients enrolled 9 gave pretreatment data 6 gave 3 day post treatment data 5 gave 7 day post treatment data\n\n1 has missing data for 7 day post treatment social relationships score'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '28'}]}]}, {'title': '3 days post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '26'}]}]}, {'title': '7 days post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '27'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'groupDescription': 'In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.'}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, 3 and 7 days post treatment', 'description': 'A questionnaire used to determine the impact and burden of a disease on daily life. This assessment has 26 questions and covers the domains of physical and psychological health, social relationships, and environment. The answers to various question are included in one or more of the domains. Raw scores are transformed in several different ways by different investigators. We report raw scores. Domains have the following raw score ranges: Overall Quality of Life 2-10, Physical Heath 7-35, Psychological Health 6-30, Social Relationships 3-15, Environment 8-40, Total Raw Score 26-130. Higher scores in each of the domains correspond to greater perceived quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients'}, {'type': 'SECONDARY', 'title': 'World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Social Relationships', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial Magnetic Stimulation', 'description': 'All patients enrolled 9 gave pretreatment data 6 gave 3 day post treatment data 5 gave 7 day post treatment data\n\n1 has missing data for 7 day post treatment social relationships score'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '15'}]}]}, {'title': '3 days post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '15'}]}]}, {'title': '7 days post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '15'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'groupDescription': 'In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.'}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline, 3 and 7 days post treatment', 'description': 'A questionnaire used to determine the impact and burden of a disease on daily life. This assessment has 26 questions and covers the domains of physical and psychological health, social relationships, and environment. The answers to various question are included in one or more of the domains. Raw scores are transformed in several different ways by different investigators. We report raw scores. Domains have the following raw score ranges: Overall Quality of Life 2-10, Physical Heath 7-35, Psychological Health 6-30, Social Relationships 3-15, Environment 8-40, Total Raw Score 26-130. Higher scores in each of the domains correspond to greater perceived quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients'}, {'type': 'SECONDARY', 'title': 'World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Environment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial Magnetic Stimulation', 'description': 'All patients enrolled 9 gave pretreatment data 6 gave 3 day post treatment data 5 gave 7 day post treatment data\n\n1 has missing data for 7 day post treatment social relationships score'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '40'}]}]}, {'title': '3 days post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000', 'lowerLimit': '31', 'upperLimit': '39'}]}]}, {'title': '7 days post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000', 'lowerLimit': '32', 'upperLimit': '43'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'groupDescription': 'In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. 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Higher scores in each of the domains correspond to greater perceived quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Transcranial Magnetic Stimulation', 'description': 'transcranial magnetic stimulation\n\ntranscranial magnetic stimulation: Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Transcranial Magnetic Stimulation', 'description': 'transcranial magnetic stimulation\n\ntranscranial magnetic stimulation: Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '2 of the 9 participants withdrew participant prior to the collection of baseline data. All 7 participants from whom data was collected are reported here.'}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2021-01-21', 'size': 210831, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-02-12T13:38', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a device study and therefore does not have a drug, biological/vaccine or combination product involved.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-15', 'studyFirstSubmitDate': '2015-12-10', 'resultsFirstSubmitDate': '2021-01-21', 'studyFirstSubmitQcDate': '2015-12-14', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-15', 'studyFirstPostDateStruct': {'date': '2015-12-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Young Mania Rating Scale (YMRS)', 'timeFrame': 'pre-treatment, 3 and 7 days post treatment', 'description': "The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours.\n\nThe YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania."}], 'primaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': '7 days', 'description': 'Participants are asked to rate pain on a100 mm visual analogue scale with 0 representing no pain and 100 representing worst possible pain. The mean difference from baseline to 7 days post-treatment is recorded.'}], 'secondaryOutcomes': [{'measure': 'World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Overall', 'timeFrame': 'pre-treatment, 3 and 7 days post treatment', 'description': 'A questionnaire used to determine the impact and burden of a disease on daily life. This assessment has 26 questions and covers the domains of physical and psychological health, social relationships, and environment. The answers to various question are included in one or more of the domains. Raw scores are transformed in several different ways by different investigators. We report raw scores. Domains have the following raw score ranges: Overall Quality of Life 2-10, Physical Heath 7-35, Psychological Health 6-30, Social Relationships 3-15, Environment 8-40, Total Raw Score 26-130. Higher scores in each of the domains correspond to greater perceived quality of life.'}, {'measure': 'World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Physical Health', 'timeFrame': 'baseline, 3 and 7 days post treatment', 'description': 'A questionnaire used to determine the impact and burden of a disease on daily life. This assessment has 26 questions and covers the domains of physical and psychological health, social relationships, and environment. The answers to various question are included in one or more of the domains. Raw scores are transformed in several different ways by different investigators. We report raw scores. Domains have the following raw score ranges: Overall Quality of Life 2-10, Physical Heath 7-35, Psychological Health 6-30, Social Relationships 3-15, Environment 8-40, Total Raw Score 26-130. Higher scores in each of the domains correspond to greater perceived quality of life.'}, {'measure': 'World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Psychological Health', 'timeFrame': 'baseline, 3 and 7 days post treatment', 'description': 'A questionnaire used to determine the impact and burden of a disease on daily life. This assessment has 26 questions and covers the domains of physical and psychological health, social relationships, and environment. The answers to various question are included in one or more of the domains. Raw scores are transformed in several different ways by different investigators. We report raw scores. Domains have the following raw score ranges: Overall Quality of Life 2-10, Physical Heath 7-35, Psychological Health 6-30, Social Relationships 3-15, Environment 8-40, Total Raw Score 26-130. Higher scores in each of the domains correspond to greater perceived quality of life.'}, {'measure': 'World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Social Relationships', 'timeFrame': 'baseline, 3 and 7 days post treatment', 'description': 'A questionnaire used to determine the impact and burden of a disease on daily life. This assessment has 26 questions and covers the domains of physical and psychological health, social relationships, and environment. The answers to various question are included in one or more of the domains. Raw scores are transformed in several different ways by different investigators. We report raw scores. Domains have the following raw score ranges: Overall Quality of Life 2-10, Physical Heath 7-35, Psychological Health 6-30, Social Relationships 3-15, Environment 8-40, Total Raw Score 26-130. Higher scores in each of the domains correspond to greater perceived quality of life.'}, {'measure': 'World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Environment', 'timeFrame': 'baseline, 3 and 7 days post treatment', 'description': 'A questionnaire used to determine the impact and burden of a disease on daily life. This assessment has 26 questions and covers the domains of physical and psychological health, social relationships, and environment. The answers to various question are included in one or more of the domains. Raw scores are transformed in several different ways by different investigators. We report raw scores. Domains have the following raw score ranges: Overall Quality of Life 2-10, Physical Heath 7-35, Psychological Health 6-30, Social Relationships 3-15, Environment 8-40, Total Raw Score 26-130. Higher scores in each of the domains correspond to greater perceived quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['trigeminal region pain'], 'conditions': ['Trigeminal Nerve Injuries', 'Post-herpetic Neuralgia', 'Facial Pain', 'Nervus Intermedius Neuralgia']}, 'descriptionModule': {'briefSummary': 'Complex oro-facial pain is a poorly diagnosed and poorly treated cause of significant suffering and disability. This study will explore the ability of fMRI to identify patients with complex oro-facial pain who respond to transcranial magnetic stimulation therapy.\n\nSpecific Aims:\n\n1. To establish baseline patterns of MRI in patients with chronic oro-facial pain without a definitive etiologic diagnosis.\n2. To estimate the rate of treatment success of transcranial stimulation of the primary motor cortex (M1) in these patients.\n3. To identify post-treatment MRI patterns that are associated with treatment success.', 'detailedDescription': 'Methods: Patients diagnosed with complex oral or facial pain at the UMPhysicians Complex Facial Pain Clinic who meet inclusion and exclusion criteria will be offered participation in the study. They will undergo baseline evaluation for depression with the HAM-D and MADRAS scales and for quality of life with the WHOQOL-BREF scale. Pain will be assessed using a 10 point visual analogue scale. Resting and pcasl MRI will be done within 24 hours before the first treatment. Treatment will consist of five daily sessions of motor cortex stimulation contralateral to the pain. Visual analogue pain scores will be obtained just before each treatment. Rating scales, resting and pcasl MRI will be repeated within 24 hours and at 2 weeks after the last treatment. Analysis: FMRI activation patterns will be examined by the investigators and correlated with treatment outcomes with the goal of identifying fMRI characteristics that can select patients suitable for further study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 18 and 110\n* Diagnosis of complex oro-facial pain made by the UMPhysicians Complex Facial Pain Clinic\n* Alternative treatment of proven value not available as judged by the UMPhysicians Complex Facial Pain clinic\n* One of the following types of facial pain as assessed by the Burchiel Patient Pain Rating Classification Questionnaire:\n\n * trigeminal neuralgia Type 2 (TN2)\n * trigeminal neuropathic pain (TNP)\n * trigeminal deafferentation pain (TDP)\n * post herpetic neuralgia (PHN)\n * atypical facial pain (AFP)\n * nervus intermedius neuralgia (NIN)\n* Willing and able to give informed consent\n\nExclusion Criteria:\n\n* Subject diagnosed according to the MINI as suffering from any other major Axis I disorder, such as Psychotic Disorder, Bipolar affective disorder, OCD (MDD is not contraindicated when Hamilton Depression Rating Scale -21≤26, or Beck Depression Inventory).\n* Subjects with significant suicidal risk as assessed by the investigator using the Beck Suicide Ideation scale, psychiatric interview or a history of attempted suicide in the past year.\n* Subject has a history of epilepsy or seizure (EXCEPT those therapeutically induced by ECT).\n* Subject has a history of significant head trauma with loss of consciousness for longer than 5 minutes.\n* Subject has a history of cranial surgery within 1 month of treatment.\n* Subject has metallic particles in the eye or head (exclusive of mouth), implanted cardiac pacemaker or any intra-cardiac lines, implanted neurostimulators, intra-cranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or implanted medical pumps.\n* Subject cannot pass the TMS Adult Safety Screen or the CMRR Safety Screen.\n* Subject has severe and frequent headaches not part of their facial pain syndrome.\n* Subject has a history of significant hearing loss.\n* Subjects with a significant neurological disorder or insult including, but not limited to:\n\n * Any condition likely to be associated with increased intracranial pressure\n * Space occupying brain lesion\n * History of cerebrovascular accident\n * Transient ischemic attack within two years\n * Cerebral aneurysm\n * MMSE ≤ 24\n * Parkinson's disease\n * Huntington's chorea\n * Multiple sclerosis\n* Subject with a history of substance abuse including alcoholism within the past 6 months (except nicotine and caffeine).\n* Inadequate communication with the patient.\n* Subject is under custodial care.\n* Subject is currently participating in another clinical study or enrolled in another clinical study within 30 days prior to this study.\n* Subject with unstable physical disease such as unstable cardiac disease.\n* Subject is currently on Benzodiazepine at a dose higher than 3 mg of Lorazepam or equivalent.\n* Subject has had previous treatment with TMS.\n* Women who are breast-feeding.\n* Women of childbearing potential and not using a medically accepted form of contraception when sexually active.\n* Inability to give informed consent"}, 'identificationModule': {'nctId': 'NCT02633306', 'briefTitle': 'Transcranial Magnetic Stimulation for Facial Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Complex Oro-Facial Pain: Functional Imaging Characterization and Treatment With Transcranial Magnetic Stimulation', 'orgStudyIdInfo': {'id': '1511M80284'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcranial Magnetic Stimulation', 'description': 'transcranial magnetic stimulation', 'interventionNames': ['Device: transcranial magnetic stimulation']}], 'interventions': [{'name': 'transcranial magnetic stimulation', 'type': 'DEVICE', 'description': 'Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain.', 'armGroupLabels': ['Transcranial Magnetic Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Stephen J Haines, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}