Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-29 @ 9:51 PM
Study NCT ID:
NCT01806168
Status:
COMPLETED
Last Update Posted:
2021-04-14
First Post:
2013-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
rTMS in the Treatment of PTSD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kawai.leong@vch.ca', 'phone': '604-875-8289', 'title': 'Kawai Leong, MD, MSc, FRCPC', 'organization': 'Vancouver Coastal Health / Vancouver General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Several limitations to this study should be highlighted. The sample size was limited and retention within the sham treated group further limited statistical power, which increases the possibility of both type 1 and type 2 error.\n\nWe did not verify the integrity of blinding, and we did not use imaging to define treatment targets. These are methodological considerations that should be included in future studies.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Low-frequency (1 Hz) rTMS', 'description': 'Low-frequency active stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'High-frequency (10 Hz) rTMS', 'description': 'High-frequency active stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Sham rTMS', 'description': 'Sham stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-frequency (1 Hz) rTMS', 'description': 'Low-frequency active stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2'}, {'id': 'OG001', 'title': 'High-frequency (10 Hz) rTMS', 'description': 'High-frequency active stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2'}, {'id': 'OG002', 'title': 'Sham rTMS', 'description': 'Sham stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2'}], 'classes': [{'categories': [{'measurements': [{'value': '59.80', 'spread': '35.83', 'groupId': 'OG000'}, {'value': '74.00', 'spread': '30.97', 'groupId': 'OG001'}, {'value': '65.12', 'spread': '14.97', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.046', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.021', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'a \\< 0.05'}, {'pValue': '0.65', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'a \\< 0.05'}], 'paramType': 'MEAN', 'timeFrame': 'Endpoint (treatment end) (Week 2).', 'description': 'The Clinician-Administered PTSD Scale-IV (CAPS-IV) is a semi-structured instrument that assesses the intensity, frequency, and severity of PTSD symptoms. It consists of 17 symptom items, each rated on a 0-4 scale for frequency and a 0-4 scale for intensity, with higher scores indicating greater frequency/intensity. The frequency and intensity scores are then summed to yield a total item severity score (range 0-8). The minimum score of the overall scale is 0 and maximum is 17 items \\* maximum severity score of 8 = 136 (higher scores indicating more severe symptoms).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat population analysed.'}, {'type': 'SECONDARY', 'title': 'PTSD Checklist for Civilians (PCL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-frequency (1 Hz) rTMS', 'description': 'Low-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2'}, {'id': 'OG001', 'title': 'High-frequency (10 Hz) rTMS', 'description': 'High-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2'}, {'id': 'OG002', 'title': 'Sham rTMS', 'description': 'Sham stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2'}], 'classes': [{'categories': [{'measurements': [{'value': '48.10', 'spread': '23.54', 'groupId': 'OG000'}, {'value': '53.44', 'spread': '22.80', 'groupId': 'OG001'}, {'value': '52.14', 'spread': '10.05', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.93', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'To test primary and secondary outcomes, we utilized intention to treat data and linear mixed models with a group random effect. Significance was set to a \\< 0.05.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Endpoint (Week 2).', 'description': 'The PTSD Checklist for Civilians (PCL-C) is a standardised self-report rating scale for PTSD comprising 17 items that correspond to the DSM-V symptoms of PTSD. A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 "Not at all" to 5 "Extremely".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat population analysed.'}, {'type': 'SECONDARY', 'title': 'Hamilton Depression Rating Scale, 21-item Version (HDRS-21)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-frequency (1 Hz) rTMS', 'description': 'Low-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2'}, {'id': 'OG001', 'title': 'High-frequency (10 Hz) rTMS', 'description': 'High-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2'}, {'id': 'OG002', 'title': 'Sham rTMS', 'description': 'Sham stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2'}], 'classes': [{'categories': [{'measurements': [{'value': '12.30', 'spread': '8.42', 'groupId': 'OG000'}, {'value': '11.22', 'spread': '7.99', 'groupId': 'OG001'}, {'value': '14.44', 'spread': '3.32', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Endpoint (Week 2)', 'description': 'A clinician-rated assessment of depression symptoms consisting of 21 items rated on a scale from 0 to 4, 0 to 2, or 0 to 3, with higher scores indicating greater symptom severity in all cases. Minimum score = 0; maximum score = 53 (scores \\> 23 are considered to be severe).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population analysed.'}, {'type': 'SECONDARY', 'title': 'Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-frequency (1 Hz) rTMS', 'description': 'Low-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2'}, {'id': 'OG001', 'title': 'High-frequency (10 Hz) rTMS', 'description': 'High-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2'}, {'id': 'OG002', 'title': 'Sham rTMS', 'description': 'Sham stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2'}], 'classes': [{'categories': [{'measurements': [{'value': '12.66', 'spread': '6.63', 'groupId': 'OG000'}, {'value': '15.00', 'spread': '7.15', 'groupId': 'OG001'}, {'value': '9.42', 'spread': '4.68', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.54', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Endpoint (Week 2)', 'description': 'A self-report scale to assess symptoms of depression consisting of 16 items, 9 of which contribute to a summed total score (i.e., only the highest score of items 1-4, 6-9, and 15-16 are counted). Scores range from 0-3, with higher scores indicating more severe symptoms. Total scores range from 0-27, with scores \\>= 21 considered very severe, 20-16 severe, 11-15 moderate, and 6-10 mild depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population analysed.'}, {'type': 'SECONDARY', 'title': 'Beck Anxiety Inventory (BAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-frequency (1 Hz) rTMS', 'description': 'Low-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2'}, {'id': 'OG001', 'title': 'High-frequency (10 Hz) rTMS', 'description': 'High-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2'}, {'id': 'OG002', 'title': 'Sham rTMS', 'description': 'Sham stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2'}], 'classes': [{'categories': [{'measurements': [{'value': '24.70', 'spread': '18.19', 'groupId': 'OG000'}, {'value': '22.77', 'spread': '18.78', 'groupId': 'OG001'}, {'value': '28.14', 'spread': '10.97', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.86', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Endpoint (Week 2)', 'description': 'A self-report scale to assess symptoms of anxiety, consisting of 21 items scored on a scale from 0-3, with higher scores indicating more severe symptoms. Total scores range from 0-63, with scores \\>= indicating potentially concerning levels of anxiety.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population analysed.'}, {'type': 'SECONDARY', 'title': 'Generalized Anxiety Disorder (GAD-7) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-frequency (1 Hz) rTMS', 'description': 'Low-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2'}, {'id': 'OG001', 'title': 'High-frequency (10 Hz) rTMS', 'description': 'High-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2'}, {'id': 'OG002', 'title': 'Sham rTMS', 'description': 'Sham stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2'}], 'classes': [{'categories': [{'measurements': [{'value': '11.90', 'spread': '7.03', 'groupId': 'OG000'}, {'value': '8.50', 'spread': '8.53', 'groupId': 'OG001'}, {'value': '11.75', 'spread': '5.62', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Endpoint (Week 2)', 'description': 'A brief self-report scale to assess symptoms of anxiety, consisting of 7 items each scored on a scale from 0-3, with higher scores indicating more severe symptoms. Total scores range from 0-21, with scores 0-4 suggesting minimal anxiety, 5-9 mild, 10-14 moderate, and 15-21 severe anxiety.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low-frequency (1 Hz) rTMS', 'description': 'Low-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2'}, {'id': 'FG001', 'title': 'High-frequency (10 Hz) rTMS', 'description': 'High-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2'}, {'id': 'FG002', 'title': 'Sham rTMS', 'description': 'Sham stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Received Allocated Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited from the psychiatry outpatient and community programs of Vancouver Coastal Health between 2014 and 2018. Some participants were recruited after attending an outpatient psychoeducation group but had not received formal group therapy. All assessments and treatments took place at Vancouver General Hospital in Vancouver, British Columbia, Canada.', 'preAssignmentDetails': '46 patients were assessed for eligibility. 15 were excluded: 7 did not meet inclusion criteria and 8 declined to participate. The remaining 31 patients were enrolled and randomized to one of three conditions.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Low-frequency (1 Hz) rTMS', 'description': 'Low-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2'}, {'id': 'BG001', 'title': 'High-frequency (10 Hz) rTMS', 'description': 'High-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2'}, {'id': 'BG002', 'title': 'Sham rTMS', 'description': 'Sham stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.\n\nrTMS: Magstim Super Rapid-2'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '39.2', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '43.5', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '49.5', 'spread': '6.9', 'groupId': 'BG002'}, {'value': '43.7', 'spread': '12.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '72.27', 'spread': '25.34', 'groupId': 'BG000'}, {'value': '69.44', 'spread': '18.29', 'groupId': 'BG001'}, {'value': '55.22', 'spread': '13.17', 'groupId': 'BG002'}, {'value': '66.10', 'spread': '21.35', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Clinician-Administered PTSD Scale-IV (CAPS-IV) is a semi-structured instrument that assesses the intensity, frequency, and severity of PTSD symptoms. It consists of 17 symptom items, each rated on a 0-4 scale for frequency and a 0-4 scale for intensity, with higher scores indicating greater frequency/intensity. The frequency and intensity scores are then summed to yield a total item severity score (range 0-8). The minimum score of the overall scale is 0 and maximum is 17\\*8=136, with higher scores indicating more severe symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-12-10', 'size': 426869, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2020-08-07T14:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-21', 'studyFirstSubmitDate': '2013-03-04', 'resultsFirstSubmitDate': '2020-08-07', 'studyFirstSubmitQcDate': '2013-03-05', 'lastUpdatePostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-21', 'studyFirstPostDateStruct': {'date': '2013-03-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)', 'timeFrame': 'Endpoint (treatment end) (Week 2).', 'description': 'The Clinician-Administered PTSD Scale-IV (CAPS-IV) is a semi-structured instrument that assesses the intensity, frequency, and severity of PTSD symptoms. It consists of 17 symptom items, each rated on a 0-4 scale for frequency and a 0-4 scale for intensity, with higher scores indicating greater frequency/intensity. The frequency and intensity scores are then summed to yield a total item severity score (range 0-8). The minimum score of the overall scale is 0 and maximum is 17 items \\* maximum severity score of 8 = 136 (higher scores indicating more severe symptoms).'}], 'secondaryOutcomes': [{'measure': 'PTSD Checklist for Civilians (PCL-C)', 'timeFrame': 'Endpoint (Week 2).', 'description': 'The PTSD Checklist for Civilians (PCL-C) is a standardised self-report rating scale for PTSD comprising 17 items that correspond to the DSM-V symptoms of PTSD. A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 "Not at all" to 5 "Extremely".'}, {'measure': 'Hamilton Depression Rating Scale, 21-item Version (HDRS-21)', 'timeFrame': 'Endpoint (Week 2)', 'description': 'A clinician-rated assessment of depression symptoms consisting of 21 items rated on a scale from 0 to 4, 0 to 2, or 0 to 3, with higher scores indicating greater symptom severity in all cases. Minimum score = 0; maximum score = 53 (scores \\> 23 are considered to be severe).'}, {'measure': 'Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)', 'timeFrame': 'Endpoint (Week 2)', 'description': 'A self-report scale to assess symptoms of depression consisting of 16 items, 9 of which contribute to a summed total score (i.e., only the highest score of items 1-4, 6-9, and 15-16 are counted). Scores range from 0-3, with higher scores indicating more severe symptoms. Total scores range from 0-27, with scores \\>= 21 considered very severe, 20-16 severe, 11-15 moderate, and 6-10 mild depression.'}, {'measure': 'Beck Anxiety Inventory (BAI)', 'timeFrame': 'Endpoint (Week 2)', 'description': 'A self-report scale to assess symptoms of anxiety, consisting of 21 items scored on a scale from 0-3, with higher scores indicating more severe symptoms. Total scores range from 0-63, with scores \\>= indicating potentially concerning levels of anxiety.'}, {'measure': 'Generalized Anxiety Disorder (GAD-7) Scale', 'timeFrame': 'Endpoint (Week 2)', 'description': 'A brief self-report scale to assess symptoms of anxiety, consisting of 7 items each scored on a scale from 0-3, with higher scores indicating more severe symptoms. Total scores range from 0-21, with scores 0-4 suggesting minimal anxiety, 5-9 mild, 10-14 moderate, and 15-21 severe anxiety.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Post-traumatic stress disorder', 'Repetitive transcranial magnetic stimulation', 'Civilians', 'Neurostimulation', 'Dorsolateral prefrontal cortex'], 'conditions': ['Post-traumatic Stress Disorder (PTSD)']}, 'referencesModule': {'references': [{'pmid': '40365001', 'type': 'DERIVED', 'citation': 'Rayani K, Grabovac A, Chan P, Montgomery S, Ghovanloo MR, Sacchet MD. Brain stimulation enhances dispositional mindfulness in PTSD: an exploratory sham-controlled rTMS trial. Front Psychiatry. 2025 Apr 29;16:1494567. doi: 10.3389/fpsyt.2025.1494567. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effects of repetitive transcranial magnetic stimulation (rTMS) in civilian patients with a confirmed diagnosis of post-traumatic stress disorder (PTSD). This research study will determine whether low-frequency (1 Hertz \\[Hz\\]) or high-frequency (10 Hz) rTMS over the right dorsolateral prefrontal cortex (DLPFC) has an effect on symptoms of PTSD compared to sham rTMS treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary diagnosis of PTSD as determined by a structured interview using the Mini International Neuropsychiatric Interview (MINI)\n* no change in psychotropic medications within 4 weeks before the start of rTMS\n* age \\> 19 years and \\< 70 years\n* competency to give informed consent\n\nExclusion Criteria:\n\n* any non-fixed metal object or implant (including cochlear implants) in brain, skull, scalp, or neck within 30 cm of the magnetic rTMS coil\n* implantable devices, including cardiac pacemakers and defibrillators\n* other contraindications to rTMS, including history of seizures (except childhood febrile seizures) or recent and unexplained syncope, first-degree relative with a history of epilepsy, treatment with a medication known to substantially decrease the seizure threshold, or pregnancy\n* psychiatric diagnoses of psychosis or psychotic disorder (including psychotic depression), bipolar type I disorder, or organic mental disorders\n* substance abuse/dependence within the past 3 months\n* active suicidal risk as judged by the clinician\n* borderline or antisocial personality disorder\n* acute medical illness, including cancer\n* any significant central nervous system disorder, such as brain mass, stroke, etc.'}, 'identificationModule': {'nctId': 'NCT01806168', 'briefTitle': 'rTMS in the Treatment of PTSD', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'The Role of Fast or Slow Repetitive Transcranial Magnetic Stimulation as Adjunct Therapy in Civilian Post-Traumatic Stress Disorder', 'orgStudyIdInfo': {'id': 'H12-01578'}, 'secondaryIdInfos': [{'id': 'V12-01578', 'type': 'OTHER', 'domain': 'Vancouver Coastal Health Research Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low-frequency (1 Hz) rTMS', 'description': 'Low-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.', 'interventionNames': ['Device: rTMS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High-frequency (10 Hz) rTMS', 'description': 'High-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.', 'interventionNames': ['Device: rTMS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sham rTMS', 'description': 'Sham stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.', 'interventionNames': ['Device: rTMS']}], 'interventions': [{'name': 'rTMS', 'type': 'DEVICE', 'otherNames': ['repetitive transcranial magnetic stimulation'], 'description': 'Magstim Super Rapid-2', 'armGroupLabels': ['High-frequency (10 Hz) rTMS', 'Low-frequency (1 Hz) rTMS', 'Sham rTMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Larry Ong, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vancouver Coastal Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vancouver Coastal Health', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Peter Y Chan', 'investigatorAffiliation': 'University of British Columbia'}}}}