Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-13 @ 8:28 AM
Study NCT ID:
NCT03372460
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2017-11-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
tDCS Plus Virtual Reality for PTSD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'noah_philip@brown.edu', 'phone': '4012737100', 'title': 'Dr. Noah S Philip, MD', 'phoneExt': '16200', 'organization': 'Center for Neurorestoration and Neurotechnology, VA Providence Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The COVID-19 pandemic significantly impacted recruitment, retention (particularly at the 3-month timepoint), and plausibly outcomes related to quality of life and social and occupational function.'}}, 'adverseEventsModule': {'timeFrame': 'Up to three months', 'description': 'Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.', 'eventGroups': [{'id': 'EG000', 'title': 'Active Stimulation', 'description': 'Active stimulation (tDCS) will be used in the dose of 2mA /25 min per day, for 6 sessions over the course of 2 weeks (3 sessions per week).\n\nActive stimulation: For active tDCS, the investigators will use a 1x1 configuration with the anode placed over EEG coordinates AF7/Fp1/AF3 (using the 10-20 EEG convention) and the cathode between EEG coordinate OZ and the contralateral mastoid (covering approximately PO8/P8). The investigators will use 3x3 cm sponge covered electrodes and a 2mA current for 25 minutes per session.\n\nVirtual Reality (VR): Participants will undergo VR exposure to trauma-related context.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 18, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Sham Stimulation', 'description': 'Sham tDCS uses the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current). This process will be used for each of the 6 sessions during a 2 week period.\n\nSham stimulation: For sham tDCS, the investigators will use the same electrode and sponge configuration as active tDCS, but using the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current).\n\nVirtual Reality (VR): Participants will undergo VR exposure to trauma-related context.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 18, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Head pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Scalp pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tingling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Burning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ringing or buzzing in ears', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Change in mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 18}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Changes in concentration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleepy, drowsy, or fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flickering lights', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurry vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness or lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Exacerbation of chronic gastrointestinal illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncopal episode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Treatment-emergent suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Stimulation', 'description': 'Active stimulation (tDCS) will be used in the dose of 2mA /25 min per day, for 6 sessions over the course of 2 weeks (3 sessions per week).\n\nActive stimulation: For active tDCS, the investigators will use a 1x1 configuration with the anode placed over EEG coordinates AF7/Fp1/AF3 (using the 10-20 EEG convention) and the cathode between EEG coordinate OZ and the contralateral mastoid (covering approximately PO8/P8). The investigators will use 3x3 cm sponge covered electrodes and a 2mA current for 25 minutes per session.\n\nVirtual Reality (VR): Participants will undergo VR exposure to trauma-related context.'}, {'id': 'OG001', 'title': 'Sham Stimulation', 'description': 'Sham tDCS uses the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current). This process will be used for each of the 6 sessions during a 2 week period.\n\nSham stimulation: For sham tDCS, the investigators will use the same electrode and sponge configuration as active tDCS, but using the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current).\n\nVirtual Reality (VR): Participants will undergo VR exposure to trauma-related context.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '48.6', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '45.0', 'spread': '11.9', 'groupId': 'OG001'}]}]}, {'title': 'Midpoint', 'categories': [{'measurements': [{'value': '38.5', 'spread': '14.4', 'groupId': 'OG000'}, {'value': '41.3', 'spread': '15.1', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint', 'categories': [{'measurements': [{'value': '36.0', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '38.9', 'spread': '15.1', 'groupId': 'OG001'}]}]}, {'title': '1 Month Follow-Up', 'categories': [{'measurements': [{'value': '31.4', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '37.9', 'spread': '16.6', 'groupId': 'OG001'}]}]}, {'title': '3 Month Follow-Up', 'categories': [{'measurements': [{'value': '21.2', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '32.3', 'spread': '17.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Midpoint (1 week after VR session 3), Endpoint (2 weeks after VR session 6), 1 Month Follow-up, 3 Month Follow-Up', 'description': 'The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Items are rated on how much the symptom bothered the respondent in the past month (0 = "not at all bothered by" to 4 = "extremely bothered "). A total symptom severity score (range: 0-80) can be obtained by summing the scores for each of the 20 items, with higher scores indicating more severe PTSD symptoms. PCL-5 scores at 1 month was the primary symptom outcome measure for this study.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Stimulation', 'description': 'Active stimulation (tDCS) will be used in the dose of 2mA /25 min per day, for 6 sessions over the course of 2 weeks (3 sessions per week).\n\nActive stimulation: For active tDCS, the investigators will use a 1x1 configuration with the anode placed over EEG coordinates AF7/Fp1/AF3 (using the 10-20 EEG convention) and the cathode between EEG coordinate OZ and the contralateral mastoid (covering approximately PO8/P8). The investigators will use 3x3 cm sponge covered electrodes and a 2mA current for 25 minutes per session.\n\nVirtual Reality (VR): Participants will undergo VR exposure to trauma-related context.'}, {'id': 'OG001', 'title': 'Sham Stimulation', 'description': 'Sham tDCS uses the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current). This process will be used for each of the 6 sessions during a 2 week period.\n\nSham stimulation: For sham tDCS, the investigators will use the same electrode and sponge configuration as active tDCS, but using the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current).\n\nVirtual Reality (VR): Participants will undergo VR exposure to trauma-related context.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '35.9', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '39.2', 'spread': '9.8', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint', 'categories': [{'measurements': [{'value': '39.2', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '41.6', 'spread': '9.2', 'groupId': 'OG001'}]}]}, {'title': '1 month follow-up', 'categories': [{'measurements': [{'value': '40.7', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '41.0', 'spread': '8.5', 'groupId': 'OG001'}]}]}, {'title': '3-month follow-up', 'categories': [{'measurements': [{'value': '44.3', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '47.1', 'spread': '10.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Endpoint (2 weeks after VR session 6), 1 Month Follow-Up, 3 Month Follow-Up', 'description': 'The 16-item QLESQ (short form) evaluates quality of life and other areas of change related to functioning outside of symptom domains (e.g., physical health, mood, leisure time activities, social relationships, etc.). Items are rated on how satisfied the respondent has been in the past week (1 = "very poor" to 5 = "very good "). A total raw score (range: 16-80). Higher outcomes indicate better quality of life, greater enjoyment, and satisfaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Psychophysiology (Skin Conductance Reactivity; SCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Stimulation', 'description': 'Active stimulation (tDCS) will be used in the dose of 2mA /25 min per day, for 6 sessions over the course of 2 weeks (3 sessions per week).\n\nActive stimulation: For active tDCS, the investigators will use a 1x1 configuration with the anode placed over EEG coordinates AF7/Fp1/AF3 (using the 10-20 EEG convention) and the cathode between EEG coordinate OZ and the contralateral mastoid (covering approximately PO8/P8). The investigators will use 3x3 cm sponge covered electrodes and a 2mA current for 25 minutes per session.\n\nVirtual Reality (VR): Participants will undergo VR exposure to trauma-related context.'}, {'id': 'OG001', 'title': 'Sham Stimulation', 'description': 'Sham tDCS uses the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current). This process will be used for each of the 6 sessions during a 2 week period.\n\nSham stimulation: For sham tDCS, the investigators will use the same electrode and sponge configuration as active tDCS, but using the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current).\n\nVirtual Reality (VR): Participants will undergo VR exposure to trauma-related context.'}], 'classes': [{'title': 'VR Session 1', 'categories': [{'measurements': [{'value': '0.742', 'spread': '0.093', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '0.093', 'groupId': 'OG001'}]}]}, {'title': 'VR Session 2', 'categories': [{'measurements': [{'value': '0.596', 'spread': '0.095', 'groupId': 'OG000'}, {'value': '0.503', 'spread': '0.092', 'groupId': 'OG001'}]}]}, {'title': 'VR Session 3', 'categories': [{'measurements': [{'value': '0.48', 'spread': '0.095', 'groupId': 'OG000'}, {'value': '0.539', 'spread': '0.093', 'groupId': 'OG001'}]}]}, {'title': 'VR Session 4', 'categories': [{'measurements': [{'value': '0.458', 'spread': '0.096', 'groupId': 'OG000'}, {'value': '0.475', 'spread': '0.093', 'groupId': 'OG001'}]}]}, {'title': 'VR Session 5', 'categories': [{'measurements': [{'value': '0.295', 'spread': '0.095', 'groupId': 'OG000'}, {'value': '0.492', 'spread': '0.094', 'groupId': 'OG001'}]}]}, {'title': 'VR Session 6', 'categories': [{'measurements': [{'value': '0.441', 'spread': '0.096', 'groupId': 'OG000'}, {'value': '0.492', 'spread': '0.094', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured during each tDCS+VR session, each session up to 1 hour', 'description': 'Psychophysiology will include skin conductance reactivity to specific trauma context virtual reality (VR) cues presented in the VR scenario. SCR to VR events will be measured by the phasic responses that occur after the presentation of discreet VR events. SCR will be compared from baseline to end of tDCS+VR, to correlate these measures and evaluate changes attributable to active tDCS+VR compared to sham.', 'unitOfMeasure': 'microsiemens (μS)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Inventory of Depressive Symptomatology Self-Report (IDSSR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Stimulation', 'description': 'Active stimulation (tDCS) will be used in the dose of 2mA /25 min per day, for 6 sessions over the course of 2 weeks (3 sessions per week).\n\nActive stimulation: For active tDCS, the investigators will use a 1x1 configuration with the anode placed over EEG coordinates AF7/Fp1/AF3 (using the 10-20 EEG convention) and the cathode between EEG coordinate OZ and the contralateral mastoid (covering approximately PO8/P8). The investigators will use 3x3 cm sponge covered electrodes and a 2mA current for 25 minutes per session.\n\nVirtual Reality (VR): Participants will undergo VR exposure to trauma-related context.'}, {'id': 'OG001', 'title': 'Sham Stimulation', 'description': 'Sham tDCS uses the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current). This process will be used for each of the 6 sessions during a 2 week period.\n\nSham stimulation: For sham tDCS, the investigators will use the same electrode and sponge configuration as active tDCS, but using the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current).\n\nVirtual Reality (VR): Participants will undergo VR exposure to trauma-related context.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '41.6', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '38.6', 'spread': '13.0', 'groupId': 'OG001'}]}]}, {'title': 'Midpoint', 'categories': [{'measurements': [{'value': '35.5', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '35.3', 'spread': '13.4', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint', 'categories': [{'measurements': [{'value': '34.2', 'spread': '15.1', 'groupId': 'OG000'}, {'value': '34.8', 'spread': '14.5', 'groupId': 'OG001'}]}]}, {'title': '1 Month Follow-Up', 'categories': [{'measurements': [{'value': '30.5', 'spread': '16.2', 'groupId': 'OG000'}, {'value': '32.3', 'spread': '15.5', 'groupId': 'OG001'}]}]}, {'title': '3 Month Follow-Up', 'categories': [{'measurements': [{'value': '23.4', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '27.1', 'spread': '14.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Midpoint (1 week after VR session 3), Endpoint (2 weeks after VR session 6), 1 Month Follow-up, 3 Month Follow-Up', 'description': 'The 28-item IDSSR is a self-report measure of depressive symptom severity. Each item is rated on a scale of 0 to 3 by the participant for a total minimum score of 0 and a maximum score of 84. A higher score on the IDSSR indicates increased depressive symptom severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Social and Occupational Function Scale (SOFAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Stimulation', 'description': 'Active stimulation (tDCS) will be used in the dose of 2mA /25 min per day, for 6 sessions over the course of 2 weeks (3 sessions per week).\n\nActive stimulation: For active tDCS, the investigators will use a 1x1 configuration with the anode placed over EEG coordinates AF7/Fp1/AF3 (using the 10-20 EEG convention) and the cathode between EEG coordinate OZ and the contralateral mastoid (covering approximately PO8/P8). The investigators will use 3x3 cm sponge covered electrodes and a 2mA current for 25 minutes per session.\n\nVirtual Reality (VR): Participants will undergo VR exposure to trauma-related context.'}, {'id': 'OG001', 'title': 'Sham Stimulation', 'description': 'Sham tDCS uses the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current). This process will be used for each of the 6 sessions during a 2 week period.\n\nSham stimulation: For sham tDCS, the investigators will use the same electrode and sponge configuration as active tDCS, but using the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current).\n\nVirtual Reality (VR): Participants will undergo VR exposure to trauma-related context.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '40.5', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '43.0', 'spread': '11.2', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint', 'categories': [{'measurements': [{'value': '47.2', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '48.0', 'spread': '12.2', 'groupId': 'OG001'}]}]}, {'title': '1 Month Follow-Up', 'categories': [{'measurements': [{'value': '53.1', 'spread': '13.8', 'groupId': 'OG000'}, {'value': '54.1', 'spread': '15.4', 'groupId': 'OG001'}]}]}, {'title': '3 Month Follow-Up', 'categories': [{'measurements': [{'value': '67.2', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '62.2', 'spread': '15.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Endpoint (2 weeks after VR session 6), 1 Month Follow-Up, 3 Month Follow-Up', 'description': "The SOFAS is a scale that focuses on the individual's level of social and occupational functioning and is not directly influenced by the overall severity of the individual's psychological symptoms. Any impairment in social and occupational functioning that is due to general medical conditions is considered in making the SOFAS rating. The SOFAS is usually used to rate functioning for the current period (i.e., the level of functioning at the time of the evaluation). Scores range from 0 to 100, with higher scores indicating better social and occupational functioning.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinician Administered PTSD Scale for the DSM-5 (CAPS-5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Stimulation', 'description': 'Active stimulation (tDCS) will be used in the dose of 2mA /25 min per day, for 6 sessions over the course of 2 weeks (3 sessions per week).\n\nActive stimulation: For active tDCS, the investigators will use a 1x1 configuration with the anode placed over EEG coordinates AF7/Fp1/AF3 (using the 10-20 EEG convention) and the cathode between EEG coordinate OZ and the contralateral mastoid (covering approximately PO8/P8). The investigators will use 3x3 cm sponge covered electrodes and a 2mA current for 25 minutes per session.\n\nVirtual Reality (VR): Participants will undergo VR exposure to trauma-related context.'}, {'id': 'OG001', 'title': 'Sham Stimulation', 'description': 'Sham tDCS uses the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current). This process will be used for each of the 6 sessions during a 2 week period.\n\nSham stimulation: For sham tDCS, the investigators will use the same electrode and sponge configuration as active tDCS, but using the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current).\n\nVirtual Reality (VR): Participants will undergo VR exposure to trauma-related context.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '44.8', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '40.5', 'spread': '8.1', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint', 'categories': [{'measurements': [{'value': '40.4', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '37.1', 'spread': '9.2', 'groupId': 'OG001'}]}]}, {'title': '1 Month Follow-Up', 'categories': [{'measurements': [{'value': '34.1', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '36.1', 'spread': '12.6', 'groupId': 'OG001'}]}]}, {'title': '3 Month Follow-Up', 'categories': [{'measurements': [{'value': '22.7', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '31', 'spread': '11.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Endpoint (2 weeks after VR session 6), 1 Month Follow-Up, 3 Month Follow-Up', 'description': "The CAPS-5 is the gold standard in clinician-assessed PTSD symptoms. The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. In addition to assessing the 20 DSM-5 PTSD symptoms, questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and specifications for the dissociative subtype (depersonalization and derealization). An interviewee's total severity score on the CAPS-5 represents the sum of the individual severity scores (0-4) for each of the 20 PTSD symptoms; total scores range from 0-80, with higher scores indicating more severe PTSD symptoms.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Stimulation', 'description': 'Active stimulation (tDCS) will be used in the dose of 2mA /25 min per day, for 6 sessions over the course of 2 weeks (3 sessions per week).\n\nActive stimulation: For active tDCS, the investigators will use a 1x1 configuration with the anode placed over EEG coordinates AF7/Fp1/AF3 (using the 10-20 EEG convention) and the cathode between EEG coordinate OZ and the contralateral mastoid (covering approximately PO8/P8). The investigators will use 3x3 cm sponge covered electrodes and a 2mA current for 25 minutes per session.\n\nVirtual Reality (VR): Participants will undergo VR exposure to trauma-related context.'}, {'id': 'FG001', 'title': 'Sham Stimulation', 'description': 'Sham tDCS uses the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current). This process will be used for each of the 6 sessions during a 2 week period.\n\nSham stimulation: For sham tDCS, the investigators will use the same electrode and sponge configuration as active tDCS, but using the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current).\n\nVirtual Reality (VR): Participants will undergo VR exposure to trauma-related context.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'Included in ITT Sample', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'comment': '1 Veteran discontinued due to stimulation site discomfort, not included in ITT sample.', 'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'Completed All 6 VR Sessions', 'achievements': [{'comment': 'Two completed 3 VR sessions (1 family emergency but continued study, 1 had worsening symptoms and withdrew after assessments). Two completed 2 VR sessions (1 had site discomfort and withdrew after assessments, 1 was lost to contact). One completed 1 VR session, withdrew due to COVID-19 infection.', 'groupId': 'FG000', 'numSubjects': '21'}, {'comment': 'One completed 5 VR sessions (change in health status but continued study), two completed four VR sessions (1 lost to contact, 1 had worsening symptoms and withdrew after assessments).', 'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Completed End-of-treatment Assessments', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Completed 1-month Follow-up', 'achievements': [{'comment': 'Five did not complete 1-month follow up. Of these, three were lost to contact and two were discontinued after completion of end-of-treatment assessments.', 'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Completed 3-month Follow-up', 'achievements': [{'comment': 'Nine did not complete 3-month follow up. Of these, 4 were discontinued due to worsening symptoms or decision to pursue other treatment. Two were withdrawn by PI (1 no longer eligible, 1 unrelated SAE). Three were lost to contact.', 'groupId': 'FG000', 'numSubjects': '10'}, {'comment': 'Eight did not complete 3-month follow-up. Of these, five were discontinued due to worsening symptoms or decision to pursue other treatment. Two were withdrawn by PI (1 due to increase in suicidal ideation, 1 unrelated SAE). One was lost to contact.', 'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'comment': 'Included in primary intent-to-treat (ITT) analysis (imputed)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Discontinued due to stimulation site discomfort', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Following enrollment, 10 Veterans were not randomized. Of these 10 Veterans, five were ineligible, three were lost to contact, and 2 were discontinued due to other concerns.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Stimulation', 'description': 'Active stimulation (tDCS) will be used in the dose of 2mA /25 min per day, for 6 sessions over the course of 2 weeks (3 sessions per week).\n\nActive stimulation: For active tDCS, the investigators will use a 1x1 configuration with the anode placed over EEG coordinates AF7/Fp1/AF3 (using the 10-20 EEG convention) and the cathode between EEG coordinate OZ and the contralateral mastoid (covering approximately PO8/P8). The investigators will use 3x3 cm sponge covered electrodes and a 2mA current for 25 minutes per session.\n\nVirtual Reality (VR): Participants will undergo VR exposure to trauma-related context.'}, {'id': 'BG001', 'title': 'Sham Stimulation', 'description': 'Sham tDCS uses the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current). This process will be used for each of the 6 sessions during a 2 week period.\n\nSham stimulation: For sham tDCS, the investigators will use the same electrode and sponge configuration as active tDCS, but using the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current).\n\nVirtual Reality (VR): Participants will undergo VR exposure to trauma-related context.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44', 'spread': '12', 'groupId': 'BG000'}, {'value': '47', 'spread': '9', 'groupId': 'BG001'}, {'value': '46', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'PTSD Checklist for DSM-5 (PCL-5)', 'classes': [{'categories': [{'measurements': [{'value': '48.6', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '45.0', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '46.72', 'spread': '12.02', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Total symptom severity score (range: 0-80) with higher scores indicating more severe PTSD symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Clinician-Administered PTSD Scale for DSM-5', 'classes': [{'categories': [{'measurements': [{'value': '44.8', 'spread': '8.2', 'groupId': 'BG000'}, {'value': '40.5', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '42.59', 'spread': '8.37', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Total scores range from 0-80, with higher scores indicating more severe PTSD symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)', 'classes': [{'categories': [{'measurements': [{'value': '35.9', 'spread': '8.9', 'groupId': 'BG000'}, {'value': '39.2', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '37.61', 'spread': '9.42', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The 16-item QLESQ (short form) evaluates quality of life and other areas of change related to functioning outside of symptom domains (e.g., physical health, mood, leisure time activities, social relationships, etc.). Items are rated on how satisfied the respondent has been in the past week (1 = "very poor" to 5 = "very good "). A total raw score (range: 16-80). Higher outcomes indicate better quality of life, greater enjoyment, and satisfaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Social and Occupational Function Scale (SOFAS)', 'classes': [{'categories': [{'measurements': [{'value': '40.5', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '43.0', 'spread': '11.2', 'groupId': 'BG001'}, {'value': '42.20', 'spread': '10.31', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Scores range from 0 to 100, with higher scores indicating better social and occupational functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Inventory of Depressive Symptomatology Self Report (IDSSR)', 'classes': [{'categories': [{'measurements': [{'value': '41.6', 'spread': '12.0', 'groupId': 'BG000'}, {'value': '38.6', 'spread': '13.0', 'groupId': 'BG001'}, {'value': '40.04', 'spread': '12.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Total minimum score of 0 and a maximum score of 84. A higher score on the IDSSR indicates increased depressive symptom severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-08', 'size': 610009, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-10T14:56', 'hasProtocol': True}, {'date': '2022-07-13', 'size': 275979, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-06-10T14:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double blind tDCS'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are assigned to receive either active or sham stimulation during the tDCS+VR sessions in parallel for the duration of the study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2017-11-03', 'resultsFirstSubmitDate': '2024-06-21', 'studyFirstSubmitQcDate': '2017-12-08', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-17', 'studyFirstPostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) Total Score', 'timeFrame': 'Baseline, Midpoint (1 week after VR session 3), Endpoint (2 weeks after VR session 6), 1 Month Follow-up, 3 Month Follow-Up', 'description': 'The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Items are rated on how much the symptom bothered the respondent in the past month (0 = "not at all bothered by" to 4 = "extremely bothered "). A total symptom severity score (range: 0-80) can be obtained by summing the scores for each of the 20 items, with higher scores indicating more severe PTSD symptoms. PCL-5 scores at 1 month was the primary symptom outcome measure for this study.'}, {'measure': 'Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)', 'timeFrame': 'Baseline, Endpoint (2 weeks after VR session 6), 1 Month Follow-Up, 3 Month Follow-Up', 'description': 'The 16-item QLESQ (short form) evaluates quality of life and other areas of change related to functioning outside of symptom domains (e.g., physical health, mood, leisure time activities, social relationships, etc.). Items are rated on how satisfied the respondent has been in the past week (1 = "very poor" to 5 = "very good "). A total raw score (range: 16-80). Higher outcomes indicate better quality of life, greater enjoyment, and satisfaction.'}, {'measure': 'Psychophysiology (Skin Conductance Reactivity; SCR)', 'timeFrame': 'Measured during each tDCS+VR session, each session up to 1 hour', 'description': 'Psychophysiology will include skin conductance reactivity to specific trauma context virtual reality (VR) cues presented in the VR scenario. SCR to VR events will be measured by the phasic responses that occur after the presentation of discreet VR events. SCR will be compared from baseline to end of tDCS+VR, to correlate these measures and evaluate changes attributable to active tDCS+VR compared to sham.'}], 'secondaryOutcomes': [{'measure': 'Inventory of Depressive Symptomatology Self-Report (IDSSR)', 'timeFrame': 'Baseline, Midpoint (1 week after VR session 3), Endpoint (2 weeks after VR session 6), 1 Month Follow-up, 3 Month Follow-Up', 'description': 'The 28-item IDSSR is a self-report measure of depressive symptom severity. Each item is rated on a scale of 0 to 3 by the participant for a total minimum score of 0 and a maximum score of 84. A higher score on the IDSSR indicates increased depressive symptom severity.'}, {'measure': 'Social and Occupational Function Scale (SOFAS)', 'timeFrame': 'Baseline, Endpoint (2 weeks after VR session 6), 1 Month Follow-Up, 3 Month Follow-Up', 'description': "The SOFAS is a scale that focuses on the individual's level of social and occupational functioning and is not directly influenced by the overall severity of the individual's psychological symptoms. Any impairment in social and occupational functioning that is due to general medical conditions is considered in making the SOFAS rating. The SOFAS is usually used to rate functioning for the current period (i.e., the level of functioning at the time of the evaluation). Scores range from 0 to 100, with higher scores indicating better social and occupational functioning."}, {'measure': 'Clinician Administered PTSD Scale for the DSM-5 (CAPS-5)', 'timeFrame': 'Baseline, Endpoint (2 weeks after VR session 6), 1 Month Follow-Up, 3 Month Follow-Up', 'description': "The CAPS-5 is the gold standard in clinician-assessed PTSD symptoms. The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. In addition to assessing the 20 DSM-5 PTSD symptoms, questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and specifications for the dissociative subtype (depersonalization and derealization). An interviewee's total severity score on the CAPS-5 represents the sum of the individual severity scores (0-4) for each of the 20 PTSD symptoms; total scores range from 0-80, with higher scores indicating more severe PTSD symptoms."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Transcranial Direct Current Stimulation', 'Stress Disorders, Post-Traumatic', 'Virtual Reality', 'Prefrontal Cortex', 'Veterans', 'Quality of Life'], 'conditions': ['Post-Traumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '38446471', 'type': 'BACKGROUND', 'citation': "van 't Wout-Frank M, Arulpragasam AR, Faucher C, Aiken E, Shea MT, Jones RN, Greenberg BD, Philip NS. Virtual Reality and Transcranial Direct Current Stimulation for Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2024 May 1;81(5):437-446. doi: 10.1001/jamapsychiatry.2023.5661."}]}, 'descriptionModule': {'briefSummary': 'This study tests the efficacy of combining non-invasive brain stimulation, called transcranial direct current stimulation (tDCS), with virtual reality exposure as a treatment for Veterans with chronic posttraumatic stress disorder (PTSD). Investigators tested whether this intervention improves PTSD symptoms and improves quality of life. Results from this study may be used to develop a new non-medication approach to treating chronic PTSD.', 'detailedDescription': 'PTSD is highly prevalent in Veterans and is associated with significant psychiatric and medical comorbidity, as well as poor quality of life. Despite its prevalence and impact, the success of currently available treatments is mixed, highlighting the need for novel approaches that aim to reduce symptoms and improve outcomes. Prior research demonstrated that reduced activity in a part of the brain, the ventromedial prefrontal cortex (VMPFC), is associated with an inability to regulate fear responses, preventing the generation of safety memories and allowing PTSD symptoms to persist. Targeting the VMPFC with non-invasive electrical brain stimulation may therefore alleviate these symptoms.\n\nTranscranial direct current stimulation (tDCS) is a type of non-invasive brain stimulation that may enhance the likelihood of neuronal activity in the VMPFC. In doing so, tDCS prepares the brain to respond to external stimuli and to facilitate learning and memory. Because therapeutic success from exposure to trauma-related content - as used in exposure-based therapy for PTSD - is thought to be based on an adaptive learning process, applying tDCS in combination with exposure to trauma cues may effectively boost exposure-based learning. In this study, investigators at the VA Providence Healthcare System will use a standardized virtual reality (VR) setting to deliver trauma-related content. The virtual reality setting involves three, 8-minute driving scenarios, constituting one VR session, which consist of VR stimuli (sights, sounds, smells, etc.) often encountered in combat training and in theater.\n\nEligible participants will be randomized to receive six sessions of either active tDCS plus virtual reality (tDCS+VR) or sham tDCS+VR. Clinical and self-report assessments will be completed at baseline, midpoint, and endpoint, as well as 1 and 3 months following the final VR session. Primary outcome measures occur at the 1 month timepoint. Psychophysiology (skin conductance reactivity) will be collected throughout each VR session to capture habituation. Participants will also undergo a MRI before and after completion of all six active or sham tDCS+VR sessions to assess change over time. Additionally, MRI data will be used for electrical field modeling to predict treatment response based on individually obtained electrical field values in PTSD relevant neural circuitry. Participants may also choose to participate in an optional pre-active or sham tDCS+VR session EEG and an optional 1-month follow-up MRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must be a Veteran\n* Located in the greater Providence and Boston areas\n* Have a diagnosis of chronic PTSD, meeting DSM-5 criteria\n* If in treatment, symptomatic despite ongoing stable treatment regimens for at least 6 weeks prior to study procedures.\n* Willing and able to comply with all study related procedures and visits\n* Capable of independently reading and understanding study materials and providing informed consent.\n\nExclusion Criteria:\n\nContraindications to MRI or tDCS, including:\n\n* Implanted device (e.g., deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord.\n* Skin lesions at the site of stimulation that may increase conductance (e.g., vascular moles or angiomas)\n* Pregnancy/lactation, or planning to become pregnant during the study\n* Lifetime history of moderate or severe traumatic brain injury (TBI)\n* Current unstable medical conditions\n* Current (or past if appropriate) significant neurological disorder, or lifetime history of a) seizure disorder b) primary or secondary CNS tumors c) stroke or d) cerebral aneurysm.\n\nOther exclusions:\n\n* Primary psychotic disorder\n* Bipolar I disorder\n* Active moderate/severe substance use disorders (within the last month, excluding nicotine/caffeine)\n* Active suicidal intent or plan as detected on screening instruments or in the investigative team's judgment is likely to attempt suicide within 6 months\n* Other conditions or circumstances that, in the opinion of the investigator team, have the potential to prevent completion and/or have a confounding effect on outcome assessments."}, 'identificationModule': {'nctId': 'NCT03372460', 'acronym': 'TAVRE', 'briefTitle': 'tDCS Plus Virtual Reality for PTSD', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Combined Transcranial Direct Current Stimulation and Virtual Reality for PTSD', 'orgStudyIdInfo': {'id': 'D2450-R'}, 'secondaryIdInfos': [{'id': '2017-053', 'type': 'OTHER', 'domain': 'PVAMC IRB'}, {'id': '1633742', 'type': 'OTHER', 'domain': 'PVAMC IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Stimulation', 'description': 'Active stimulation (tDCS) will be used in the dose of 2mA /25 min per day, for 6 sessions over the course of 2 weeks (3 sessions per week).', 'interventionNames': ['Device: Active stimulation', 'Other: Virtual Reality (VR)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Stimulation', 'description': 'Sham tDCS uses the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current). This process will be used for each of the 6 sessions during a 2 week period.', 'interventionNames': ['Device: Sham stimulation', 'Other: Virtual Reality (VR)']}], 'interventions': [{'name': 'Active stimulation', 'type': 'DEVICE', 'otherNames': ['Active tDCS'], 'description': 'For active tDCS, the investigators will use a 1x1 configuration with the anode placed over EEG coordinates AF7/Fp1/AF3 (using the 10-20 EEG convention) and the cathode between EEG coordinate OZ and the contralateral mastoid (covering approximately PO8/P8). The investigators will use 3x3 cm sponge covered electrodes and a 2mA current for 25 minutes per session.', 'armGroupLabels': ['Active Stimulation']}, {'name': 'Sham stimulation', 'type': 'DEVICE', 'otherNames': ['Sham tDCS'], 'description': 'For sham tDCS, the investigators will use the same electrode and sponge configuration as active tDCS, but using the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current).', 'armGroupLabels': ['Sham Stimulation']}, {'name': 'Virtual Reality (VR)', 'type': 'OTHER', 'description': 'Participants will undergo VR exposure to trauma-related context.', 'armGroupLabels': ['Active Stimulation', 'Sham Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02908-4734', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Providence VA Medical Center, Providence, RI', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Noah S. Philip, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Providence VA Medical Center, Providence, RI'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}