Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-29 @ 4:19 PM
Study NCT ID:
NCT01391832
Status:
COMPLETED
Last Update Posted:
2024-01-22
First Post:
2011-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Novel Treatment of Emotional Dysfunction in Post Traumatic Stress Disorder (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'}, {'id': 'C000708228', 'term': '2-cyclohexylidenhydrazo-4-phenyl-thiazole'}, {'id': 'D001521', 'term': 'Behavior Therapy'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jill.ritter@utdallas.edu', 'phone': '972-883-4853', 'title': 'Dr. John Hart, Jr.', 'organization': 'University of Texas at Dallas'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '10 months', 'description': 'Two participants assigned to receive rTMS and one participant assigned to receive sham rTMS reported headaches and requested termination of the rTMS portion of the therapy.', 'eventGroups': [{'id': 'EG000', 'title': 'Sham rTMS', 'description': 'Sham Treatment Intervention: Device: Repetitive Transcranial Magnet Stimulation (sham treatment)\n\nRepetitive Transcranial Magnetic Stimulation (rTMS): For the sham rTMS with CPT group, the rTMS coil will be placed over the right prefrontal scalp region with the MagStim Rapid Stimulator set to the sham mode so that all conditions are similar to the active delivery mode except that transcranial magnetic stimulation is not administered to the scalp and does not down modulate the right frontal lobe.\n\nCognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the combat related trauma.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 1, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Active rTMS', 'description': 'Active Repetitive Transcranial Magnet Stimulation treatment\n\nIntervention: Device: Active rTMS of dorsolateral pre-frontal cortex\n\nCognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the combat related trauma.\n\nRepetitive Transcranial Magnet Stimulation (rTMS): For the active rTMS with CPT group, the rTMS coil was be placed over over the dorsolateral prefrontal cortex - DLPFC (Brodmann Area 9/46) and stimulation provided at 1 Hz (1.5-2.0 Tesla strength, 100 - 300 microseconds.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 2, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'notes': 'Two participants assigned to receive rTMS and one participant assigned to receive sham rTMS reported headaches and requested termination of the rTMS portion of the therapy.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Headache MedDRA10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Follow-up in Clinician Administered Post-Traumatic Stress Disorder Scale Total Severity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham rTMS', 'description': 'Sham Treatment Intervention: Device: Repetitive Transcranial Magnet Stimulation (sham treatment)\n\nThe rTMS coil will be placed over the right prefrontal scalp region, simulating targeting DLPFC (Brodmann Area 9/46), with the MagStim Rapid Stimulator set to the sham mode so that all conditions are similar to the active delivery mode except that transcranial magnetic stimulation is not administered to the scalp.\n\nCognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access memory of the traumatic event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself, about self and the world which have been altered.'}, {'id': 'OG001', 'title': 'Active rTMS', 'description': 'Active Repetitive Transcranial Magnet Stimulation treatment\n\nIntervention: Device: Active rTMS of dorsolateral pre-frontal cortex The rTMS coil will be placed over the right prefrontal scalp region, targeting DLPFC (Brodmann Area 9/46), with the MagStim Rapid Stimulator set to the active mode. Alternating current turned on and off rapidly produces magnetic pulses (1.5-2.0 Tesla strength) that last for 100 - 300 microseconds (1 HZ at 110% of motor-threshold).\n\nCognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access memory of the traumatic event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself, about self and the world which have been altered.'}], 'classes': [{'title': '1 month change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-35.59', 'spread': '4.22', 'groupId': 'OG000'}, {'value': '-44.164', 'spread': '3.8226', 'groupId': 'OG001'}]}]}, {'title': '3 month change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-33.19', 'spread': '4.24', 'groupId': 'OG000'}, {'value': '-44.95', 'spread': '3.85', 'groupId': 'OG001'}]}]}, {'title': '6 month change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-36.31', 'spread': '4.24', 'groupId': 'OG000'}, {'value': '-47.76', 'spread': '3.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 't-value on group differences in change', 'ciNumSides': 'ONE_SIDED', 'paramValue': '-1.51', 'pValueComment': 'Predicted effects on symptom reduction were evaluated with α = 0.05 for one-tailed t-distributions, recommended for designs examining efficacy of therapeutic interventions (Overall, 1991).', 'estimateComment': 'degrees of freedom = 327', 'groupDescription': 'Restricted maximum likelihood estimators (ReML) of the variance components were used to compute the maximum likelihood estimators of the fixed effects parameters (i.e., group, time, therapist, all two-way interaction terms, and the three-way interaction term). Thus, we did not exclude participants with missing time points.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Restricted maximum likelihood estimators of variance components for fixed effects; Satterthwaite estimates of effective degrees of freedom.', 'nonInferiorityComment': 'Comparison of differences between rTMS+CPT and sham+CPT groups in change Clinical Administered Post-Traumatic Scale Total Severity Scores from baseline to 1-month follow-up.'}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 't-value on group differences in change', 'ciNumSides': 'ONE_SIDED', 'paramValue': '-2.05', 'pValueComment': 'Predicted effects on symptom reduction were evaluated with α = 0.05 for one-tailed t-distributions, recommended for designs examining efficacy of therapeutic interventions (Overall, 1991).', 'estimateComment': 'degrees of freedom = 327', 'groupDescription': 'Restricted maximum likelihood estimators (ReML) of the variance components were used to compute the maximum likelihood estimators of the fixed effects parameters (i.e., group, time, therapist, all two-way interaction terms, and the three-way interaction term). Thus, we did not exclude participants with missing time points.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Restricted maximum likelihood estimators of variance components for fixed effects; Satterthwaite estimates of effective degrees of freedom.', 'nonInferiorityComment': 'Comparison of differences between rTMS+CPT and sham+CPT groups in change Clinical Administered Post-Traumatic Scale Total Severity Scores from baseline to 3-month follow-up.'}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 't-value on group differences in change', 'ciNumSides': 'ONE_SIDED', 'paramValue': '-2.01', 'pValueComment': 'Predicted effects on symptom reduction were evaluated with α = 0.05 for one-tailed t-distributions, recommended for designs examining efficacy of therapeutic interventions (Overall, 1991).', 'estimateComment': 'degrees of freedom = 327', 'groupDescription': 'Restricted maximum likelihood estimators (ReML) of the variance components were used to compute the maximum likelihood estimators of the fixed effects parameters (i.e., group, time, therapist, all two-way interaction terms, and the three-way interaction term). Thus, we did not exclude participants with missing time points.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Restricted maximum likelihood estimators of variance components for fixed effects; Satterthwaite estimates of effective degrees of freedom.', 'nonInferiorityComment': 'Comparison of differences between rTMS+CPT and sham+CPT groups in change Clinical Administered Post-Traumatic Scale Total Severity Scores from baseline to 6-month follow-up.'}], 'paramType': 'MEAN', 'timeFrame': 'Outcome measures will be measured as change from baseline at 1-, 3-, and 6-month follow-ups', 'description': 'The primary outcome measure of treatment efficacy for post-traumatic stress disorder (PTSD) will be change in the Clinician Administered Post-Traumatic Stress Disorder Scale (CAPS) Total Severity Score (i.e., summed across frequency and intensity ratings for the 17 PTSD assessment items) from baseline at 1-month post-treatment. CAPS Total Severity Score ranges from 0 to 136. Difference scores were calculated as the outcome score minus the baseline score, with negative scores indicating a reduction in symptom severity from baseline (i.e., a positive treatment outcome), and differences between treatment groups in change scores were evaluated using t-tests.', 'unitOfMeasure': 'change in scale score from baseline', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Veterans previously deployed to combat regions from 2001 to present (e.g., Operation Enduring Freedom (OEF), Operation Iraq Freedom (OIF), and Operation New Dawn (OND)) with current combat-related PTSD symptoms were recruited from the community. 103 were enrolled and randomly assigned to the treatment arms on a parallel 1:1 basis.'}, {'type': 'SECONDARY', 'title': 'Changes in ERP/CAPS Cluster Scores Signals From Pre-Treatment to Post-Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham rTMS', 'description': 'Sham Treatment Intervention: Device: Repetitive Transcranial Magnet Stimulation (sham treatment)\n\nThe rTMS coil will be placed over the right prefrontal scalp region, simulating targeting DLPFC (Brodmann Area 9/46), with the MagStim Rapid Stimulator set to the sham mode so that all conditions are similar to the active delivery mode except that transcranial magnetic stimulation is not administered to the scalp.\n\nCognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access memory of the traumatic event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself, about self and the world which have been altered.'}, {'id': 'OG001', 'title': 'Active rTMS', 'description': 'Active Repetitive Transcranial Magnet Stimulation treatment\n\nIntervention: Device: Active rTMS of dorsolateral pre-frontal cortex The rTMS coil will be placed over the right prefrontal scalp region, targeting DLPFC (Brodmann Area 9/46), with the MagStim Rapid Stimulator set to the active mode. Alternating current turned on and off rapidly produces magnetic pulses (1.5-2.0 Tesla strength) that last for 100 - 300 microseconds (1 HZ at 110% of motor-threshold).\n\nCognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access memory of the traumatic event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself, about self and the world which have been altered.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2754', 'spread': '3.095', 'groupId': 'OG000'}, {'value': '-0.6088', 'spread': '2.278', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.3422', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '1.422', 'paramValue': '-0.666', 'ciLowerLimit': '-0.7548', 'ciUpperLimit': '2.088', 'pValueComment': 'It is not adjusted for multiple comparisons.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.7101', 'estimateComment': 'mean change from baseline to 6-month follow-up, rTMS Active - rTMS Sham', 'groupDescription': 'Null hypothesis test of differences in N2 micro-volt change from baseline to 6-month followup.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'degrees of freedom = 58'}, {'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-.30', 'pValueComment': 'Not adjusted', 'groupDescription': 'The analysis examined the association between change in PTSD symptoms from baseline to 6-month follow-up and the change in N2 amplitude to the threatening stimulus from baseline to 6-month follow-up.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The analysis examined correlations in change in N2 and PTSD symptoms.', 'otherAnalysisDescription': 'Correlations for the individual groups were active rTMS r(28)=-.373 and sham rTMS r(32)=-.296.'}], 'paramType': 'MEAN', 'timeFrame': 'Outcomes will be assessed at baseline and 6-month follow-up', 'description': 'The secondary outcome measures will be a) the ERP measures of P3a amplitude for hyperarousal to combat threatening stimuli will be compared from post- to pre-treatment b) the total CAPS scores from pre-treatment and post-treatment will be compared.', 'unitOfMeasure': 'micro-volts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Sixty participants (6 female) of the 103 completed the study protocol and returned for 6-month follow-up evaluation; the data from those 60 veterans were analyzed and reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sham rTMS', 'description': 'Sham Treatment Intervention: Device: Repetitive Transcranial Magnet Stimulation (sham treatment)\n\nRepetitive Transcranial Magnetic Stimulation (rTMS): For the sham rTMS with CPT group, the rTMS coil will be placed over the right prefrontal scalp region with the MagStim Rapid Stimulator set to the sham mode so that all conditions are similar to the active delivery mode except that transcranial magnetic stimulation is not administered to the scalp and does not down modulate the right frontal lobe.\n\nCognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been alte'}, {'id': 'FG001', 'title': 'Active rTMS', 'description': 'Active Repetitive Transcranial Magnet Stimulation treatment\n\nIntervention: Device: Active rTMS of dorsolateral pre-frontal cortex\n\nCognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the combat related trauma.\n\nRepetitive Transcranial Magnet Stimulation (rTMS): For the active rTMS with CPT group, the rTMS coil will be placed over the right prefrontal scalp region with the MagStim Rapid Stimulator set to the active mode. After motor threshold determination, the stimulator coil is positioned over the dorsolateral prefrontal cortex - D'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': '1 Month Follow-Up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': '3 Month Follow-Up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Veterans previously deployed to combat regions from 2001 to present (e.g., Operation Enduring Freedom (OEF), Operation Iraq Freedom (OIF), and Operation New Dawn (OND) with current combat-related PTSD symptoms were recruited from the community.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sham rTMS', 'description': 'Sham Treatment Intervention: Device: Repetitive Transcranial Magnet Stimulation (sham treatment)\n\nRepetitive Transcranial Magnetic Stimulation (rTMS): For the sham rTMS with CPT group, the rTMS coil will be placed over the right prefrontal scalp region with the MagStim Rapid Stimulator set to the sham mode so that all conditions are similar to the active delivery mode except that transcranial magnetic stimulation is not administered to the scalp and does not down modulate the right frontal lobe.\n\nCognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the combat related trauma.'}, {'id': 'BG001', 'title': 'Active rTMS', 'description': 'Active Repetitive Transcranial Magnet Stimulation treatment\n\nIntervention: Device: Active rTMS of dorsolateral pre-frontal cortex\n\nCognitive Processing Therapy (CPT): CPT is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the combat related trauma.\n\nRepetitive Transcranial Magnet Stimulation (rTMS): For the active rTMS with CPT group, the rTMS coil was be placed over over the dorsolateral prefrontal cortex - DLPFC (Brodmann Area 9/46) and stimulation provided at 1 Hz (1.5-2.0 Tesla strength, 100 - 300 microseconds.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.39', 'spread': '6.13', 'groupId': 'BG000'}, {'value': '32.89', 'spread': '7.60', 'groupId': 'BG001'}, {'value': '32.65', 'spread': '6.91', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Veterans previously deployed to combat regions from 2001 to present (e.g., Operation Enduring Freedom (OEF), Operation Iraq Freedom (OIF), and Operation New Dawn (OND) with current combat-related PTSD symptoms were recruited from the community.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-18', 'studyFirstSubmitDate': '2011-07-05', 'resultsFirstSubmitDate': '2020-08-05', 'studyFirstSubmitQcDate': '2011-07-08', 'lastUpdatePostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-09', 'studyFirstPostDateStruct': {'date': '2011-07-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Follow-up in Clinician Administered Post-Traumatic Stress Disorder Scale Total Severity Score', 'timeFrame': 'Outcome measures will be measured as change from baseline at 1-, 3-, and 6-month follow-ups', 'description': 'The primary outcome measure of treatment efficacy for post-traumatic stress disorder (PTSD) will be change in the Clinician Administered Post-Traumatic Stress Disorder Scale (CAPS) Total Severity Score (i.e., summed across frequency and intensity ratings for the 17 PTSD assessment items) from baseline at 1-month post-treatment. CAPS Total Severity Score ranges from 0 to 136. Difference scores were calculated as the outcome score minus the baseline score, with negative scores indicating a reduction in symptom severity from baseline (i.e., a positive treatment outcome), and differences between treatment groups in change scores were evaluated using t-tests.'}], 'secondaryOutcomes': [{'measure': 'Changes in ERP/CAPS Cluster Scores Signals From Pre-Treatment to Post-Treatment', 'timeFrame': 'Outcomes will be assessed at baseline and 6-month follow-up', 'description': 'The secondary outcome measures will be a) the ERP measures of P3a amplitude for hyperarousal to combat threatening stimuli will be compared from post- to pre-treatment b) the total CAPS scores from pre-treatment and post-treatment will be compared.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['rTMS', 'PTSD', 'Post Traumatic Stress Disorder', 'repetitive transcranial magnetic stimulation', 'combat related PTSD', 'OEF', 'OIF', 'Veterans', 'operation enduring freedom', 'operation iraqi freedom', 'CPT', 'cognitive processing therapy'], 'conditions': ['Post Traumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': 'The objective will be to determine if adding repetitive transcranial magnetic stimulation prior to Cognitive Processing Therapy significantly enhances recovery from hyperarousal symptoms in individuals with combat related post traumatic stress disorder and improves clinical outcome.\n\nThe investigators have assembled a multimodal human performance laboratory including 64 channel EEG and repetitive transcranial magnetic stimulation system. These resources combined with the neuroimaging capabilities of the Advanced Imaging Research Center (AIRC) at UT Southwestern and skilled Cognitive Processing Therapy (CPT) practitioners will be used in this study.\n\nThe study involves approximately 19 visits. Treatment is once a week for 12 weeks followed by a 1 month, 3 month and 6 month follow-up appointments.', 'detailedDescription': 'We will first screen participants between the ages of 18 and 60 years for symptoms of PTSD as determined by subjective reporting. We will also screen for healthy control participants to participate in comparison assessment phases of the study. After meeting pre-screen criteria, a more extensive screening to determine the eligibility of each subject will be performed. This will be followed by an EEG. The EEG system measures event-related potentials (ERPs), which explain certain cognitive processes based on changes in the amplitude and timing of electrical changes recorded from the surface of the scalp. We will use an ERP task that includes combat-threatening stimuli as the novel oddball probe to assess P300 response. The amplitude of the P300 (positive amplitude recorded 300 milliseconds after stimulus onset) is used to differentiate between hypo-, normo-, and hyper-arousability. Identifying those with hyperarousal on P300 response on ERP allows for identification of PTSD patients with subjective and objective measures of hyperarousal. The participants will then be scheduled for a neuroimaging session. During neuroimaging, participants will have structural and functional brain scans acquired, including a functional MRI scan using the same threatening/nonthreatening stimuli, thus providing another objective measure of hyperarousal.\n\nParticipants will then have active or sham 1 Hz repetitive transcranial magnetic stimulation (rTMS) administered to the right frontal lobe as well as Cognitive Processing Therapy (CPT) once per week for twelve weeks (total 12 rTMS-CPT sessions). Studies have shown that rTMS applied externally to the forehead in the region of the dorsal lateral forehead will safely, reversibly, and painlessly down-modulate the frontal lobe on the side of the head to which it is applied. Our preliminary studies have shown that application of frontal rTMS can reduce the response to threatening stimuli temporarily and this can optimize the effectiveness of the CPT. Following the 12 sessions of rTMS-CPT, the EEG and neuroimaging will be repeated to test for changes in brain function.\n\nIn summary, the study involves approximately 19 visits. Treatment is once a week for 12 weeks followed by a 1 month, 3 month and 6 month follow-up appointments.\n\n* The first 2-3 visits involve an informed consent, a baseline assessment, EEG and neuroimaging.\n* Visits 4-15 are the rTMS/CPT sessions.\n* Visit 16 is a 1 month follow-up, post-treatment assessment and EEG.\n* Visit 17 is a post-treatment neuroimaging visit.\n* Visit 18 is the 3 month follow up assessment.\n* Visit 19 is the 6 month follow-up assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Veterans of Operation Iraqi Freedom (OIF) or Operation Enduring Freedom (OEF)\n* 18-60 years\n* Diagnosis or symptoms of Combat related PTSD/ PCL Score Indicative of diagnosis (prior diagnosis not required).\n* English speaking\n* Participants will be screened for exclusionary medical and mental health history.\n\nThis study is also looking for civilian and miltary control subjects for assessment phase participation.'}, 'identificationModule': {'nctId': 'NCT01391832', 'briefTitle': 'Novel Treatment of Emotional Dysfunction in Post Traumatic Stress Disorder (PTSD)', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas at Dallas'}, 'officialTitle': 'Novel Treatment of Emotional Dysfunction in PTSD', 'orgStudyIdInfo': {'id': '092010-035'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham rTMS', 'description': 'Sham Treatment Intervention: Device: Repetitive Transcranial Magnet Stimulation (sham treatment)', 'interventionNames': ['Device: Repetitive Transcranial Magnetic Stimulation (rTMS)', 'Behavioral: Cognitive Processing Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'active rTMS', 'description': 'Active Repetitive Transcranial Magnet Stimulation treatment\n\nIntervention: Device: Active rTMS of dorsolateral pre-frontal cortex', 'interventionNames': ['Behavioral: Cognitive Processing Therapy', 'Device: Repetitive Transcranial Magnet Stimulation (rTMS)']}], 'interventions': [{'name': 'Repetitive Transcranial Magnetic Stimulation (rTMS)', 'type': 'DEVICE', 'otherNames': ['rTMS', 'magnet stimulation'], 'description': 'For the sham rTMS with CPT group, the rTMS coil will be placed over the right prefrontal scalp region with the MagStim Rapid Stimulator set to the sham mode so that all conditions are similar to the active delivery mode except that transcranial magnetic stimulation is not administered to the scalp and does not down modulate the right frontal lobe.', 'armGroupLabels': ['Sham rTMS']}, {'name': 'Cognitive Processing Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['CPT', 'behavioral training', 'behavioral therapy'], 'description': 'Cognitive Processing Therapy (CPT) is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the combat related trauma.', 'armGroupLabels': ['Sham rTMS', 'active rTMS']}, {'name': 'Repetitive Transcranial Magnet Stimulation (rTMS)', 'type': 'DEVICE', 'description': 'For the active rTMS with CPT group, the rTMS coil will be placed over the right prefrontal scalp region with the MagStim Rapid Stimulator set to the active mode. After motor threshold determination, the stimulator coil is positioned over the dorsolateral prefrontal cortex - DLPFC (Brodmann Area 9/46). The right frontal rTMS will safely, reversibly, and temporarily down modulate the right frontal lobe. The conducting coil is placed over the scalp while electrical current pulses pass through the coil. This alternating current turned on and off rapidly produces magnetic pulses (1.5-2.0 Tesla strength) that last for 100 - 300 microseconds. The time-varying magnetic pulses induce an electrical field that will result in current flow in neural tissue, thereby activating or deactivating cortex subjacent to the coil.', 'armGroupLabels': ['active rTMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas at Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'John Hart Jr., M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas at Dallas'}, {'name': 'F. Andrew Kozel, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Texas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas at Dallas', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}, {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'John Hart, Jr.', 'investigatorAffiliation': 'The University of Texas at Dallas'}}}}