Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT05772702
Status:
COMPLETED
Last Update Posted:
2025-05-29
First Post:
2023-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chris.walker@pulvinarneuro.com', 'phone': '8043173403', 'title': 'Dr. Christopher Walker', 'organization': 'Pulvinar Neuro'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected across the full study participation (89 days). A structured adverse event was administered on D5 for all participants and for any AE spontaneously reported by a participant.', 'eventGroups': [{'id': 'EG000', 'title': 'Closed-loop tACS', 'description': 'Closed-loop individual alpha tACS daily for five consecutive days.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 21, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'notes': 'Nausea, time-limited to the stimulation session', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'notes': "Vomiting, time-limited to the stimulation session, determined by study physician to likely be related to participant's undisclosed COVID-19 infection.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'notes': 'Diarrhea reported during the treatment week', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'Headache, time-limited to the stimulation session', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin irritation', 'notes': 'Skin irritation at electrode sites, time-limited to the stimulation session', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Scalp/neck pain', 'notes': 'Scalp/neck pain, time-limited to the stimulation session', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'notes': 'Dizziness, time-limited to the stimulation session', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'notes': 'Fatigue, increased tiredness time-limited to the stimulation session', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle cramps', 'notes': 'Muscle cramps, time-limited to the stimulation session', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Hamilton Depression Rating Scale 17-item (HDRS-17)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-loop tACS', 'description': 'Closed-loop individual alpha tACS daily for five consecutive days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.04', 'spread': '4.83', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0005', 'groupIds': ['OG000'], 'groupDescription': 'HDRS-17 change score were submitted to a t-test to estimate the group difference from 0 (i.e., no change in depression symptoms from D1 to FU2). Null hypothesis: D1 == FU2', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Day 19 (i.e. 19 days)', 'description': 'Change in HDRS-17 from Day 1 (D1) to Day 19 (i.e., two week follow-up; FU2); HDRS-17 minimum value is 0, maximum value is 52. Higher scores indicate worse outcome. Negative scores indicate improved outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Hamilton Depression Rating Scale 17-item (HDRS-17)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-loop tACS', 'description': 'Closed-loop individual alpha tACS daily for five consecutive days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.36', 'spread': '4.41', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0005', 'groupIds': ['OG000'], 'groupDescription': 'HDRS-17 change score were submitted to a t-test to estimate the group difference from 0 (i.e., no change in depression symptoms from D1 to D5). Note: D5 HDRS-17 were determined prior to receiving the final treatment on D5. Null hypothesis: D1 == D5', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Day 5 (i.e., 5 days)', 'description': 'Change in HDRS-17 from Day 1 (D1) to Day 5 (D5); HDRS-17minimum value is 0, maximum value is 52. Higher scores indicate worse outcome. Negative scores indicate improved outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Response/Remission of Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-loop tACS', 'description': 'Closed-loop individual alpha tACS daily for five consecutive days.'}], 'classes': [{'title': 'Response at D5', 'categories': [{'title': 'Met criteria', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Did not meet criteria', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Response at FU2', 'categories': [{'title': 'Met criteria', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Did not meet criteria', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Remission at D5', 'categories': [{'title': 'Met criteria', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Did not meet criteria', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Remission at FU2', 'categories': [{'title': 'Met criteria', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Did not meet criteria', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 5 and Day 19', 'description': 'Number of response/remission rates at Day 5 (D5) and Day 19 (i.e., two week follow-up; FU2). Response defined as \\>=50% reduction in HDRS-17 from D1. Remission defined as HDRS-17 score \\<=7.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Quick Inventory of Depressive Symptomatology (QIDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-loop tACS', 'description': 'Closed-loop individual alpha tACS daily for five consecutive days.'}], 'classes': [{'title': 'D5-D1', 'categories': [{'measurements': [{'value': '-3.88', 'spread': '3.23', 'groupId': 'OG000'}]}]}, {'title': 'FU1-D1', 'categories': [{'measurements': [{'value': '-5.96', 'spread': '3.51', 'groupId': 'OG000'}]}]}, {'title': 'FU2-D1', 'categories': [{'measurements': [{'value': '-7.48', 'spread': '3.90', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0005', 'groupIds': ['OG000'], 'groupDescription': 'QIDS change score were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 QIDS surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': "Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.", 'nonInferiorityComment': 'This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)', 'description': 'Change in QIDS at Day 5 (D5), Day 12 (i.e., one-week follow-up; FU1), and Day 19 (i.e., two-week follow-up; FU2); QIDS minimum value is 0, maximum value is 27. Higher scores indicate worse outcome. Negative scores indicate improved outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Altman Self-Rating Mania Scale (ASRM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-loop tACS', 'description': 'Closed-loop individual alpha tACS daily for five consecutive days.'}], 'classes': [{'title': 'D5-D1', 'categories': [{'measurements': [{'value': '0.88', 'spread': '1.81', 'groupId': 'OG000'}]}]}, {'title': 'FU1-D1', 'categories': [{'measurements': [{'value': '1.92', 'spread': '1.93', 'groupId': 'OG000'}]}]}, {'title': 'FU2-D1', 'categories': [{'measurements': [{'value': '1.92', 'spread': '1.89', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0005', 'groupIds': ['OG000'], 'groupDescription': 'ASRM scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 ASRM surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)', 'description': 'Change in ASRM at Day 5 (D5), Day 12 (i.e., one week follow-up; FU1), and Day 19 (i.e., two week follow-up; FU2); ASRM minimum value is 0, maximum value is 20. Higher scores indicate worse outcome. Negative scores indicate improved outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Snaith-Hamilton Pleasure Scale (SHAPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-loop tACS', 'description': 'Closed-loop individual alpha tACS daily for five consecutive days.'}], 'classes': [{'title': 'D5-D1', 'categories': [{'measurements': [{'value': '-2.60', 'spread': '2.61', 'groupId': 'OG000'}]}]}, {'title': 'FU1-D1', 'categories': [{'measurements': [{'value': '-3.48', 'spread': '3.40', 'groupId': 'OG000'}]}]}, {'title': 'FU2-D1', 'categories': [{'measurements': [{'value': '-3.76', 'spread': '3.44', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0005', 'groupIds': ['OG000'], 'groupDescription': 'SHAPS scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 SHAPS surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': "Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.", 'nonInferiorityComment': 'This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)', 'description': 'Change in SHAPS from Day 1 (D1) to Day 5 (D5), Day 12 (i.e., one week follow-up; FU1), and Day 19 (i.e., two week follow-up; FU2); SHAPS minimum value is 0, maximum value is 14. Higher scores indicate worse outcome. Negative scores indicate improved outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Depression Anxiety and Stress Scale (DASS-42)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-loop tACS', 'description': 'Closed-loop individual alpha tACS daily for five consecutive days.'}], 'classes': [{'title': 'Overall: D5-D1', 'categories': [{'measurements': [{'value': '-12.52', 'spread': '14.39', 'groupId': 'OG000'}]}]}, {'title': 'Overall: FU1-D1', 'categories': [{'measurements': [{'value': '-21.44', 'spread': '16.63', 'groupId': 'OG000'}]}]}, {'title': 'Overall: FU2-D1', 'categories': [{'measurements': [{'value': '-24.08', 'spread': '18.92', 'groupId': 'OG000'}]}]}, {'title': 'Depression Subscale: D5-D1', 'categories': [{'measurements': [{'value': '-6.52', 'spread': '8.15', 'groupId': 'OG000'}]}]}, {'title': 'Depression Subscale: FU1-D1', 'categories': [{'measurements': [{'value': '-11.00', 'spread': '7.53', 'groupId': 'OG000'}]}]}, {'title': 'Depression Subscale: FU2-D1', 'categories': [{'measurements': [{'value': '-12.20', 'spread': '8.90', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety Subscale: D5-D1', 'categories': [{'measurements': [{'value': '-1.88', 'spread': '2.57', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety Subscale: FU1-D1', 'categories': [{'measurements': [{'value': '-2.84', 'spread': '4.04', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety Subscale: FU2-D1', 'categories': [{'measurements': [{'value': '-3.64', 'spread': '4.51', 'groupId': 'OG000'}]}]}, {'title': 'Stress Subscale: D5-D1', 'categories': [{'measurements': [{'value': '-4.12', 'spread': '6.73', 'groupId': 'OG000'}]}]}, {'title': 'Stress Subscale: FU1-D1', 'categories': [{'measurements': [{'value': '-7.60', 'spread': '8.99', 'groupId': 'OG000'}]}]}, {'title': 'Stress Subscale: FU2-D1', 'categories': [{'measurements': [{'value': '-8.24', 'spread': '9.47', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0005', 'groupIds': ['OG000'], 'groupDescription': 'DASS-42 OVERALL scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': "Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.", 'nonInferiorityComment': 'This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.'}, {'pValue': '<0.0005', 'groupIds': ['OG000'], 'groupDescription': 'DASS-42 DEPRESSION SUBSCORES were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'This subscale did not require sphericity corrections.', 'nonInferiorityComment': 'This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.'}, {'pValue': '<0.0005', 'groupIds': ['OG000'], 'groupDescription': 'DASS-42 ANXIETY SUBSCORES were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': "Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.", 'nonInferiorityComment': 'This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.'}, {'pValue': '<0.0005', 'groupIds': ['OG000'], 'groupDescription': 'DASS-42 STRESS SUBSCORES were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': "Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.", 'nonInferiorityComment': 'This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)', 'description': 'Change in DASS-42 from Day 1 (D1) to Day 5 (D5), Day 12 (i.e., one week follow-up; FU1), and Day 19 (i.e., two week follow-up; FU2); DASS-42 minimum value is 0, maximum value is 126 with three subscales (0 to 42). Higher scores indicate worse outcome. Negative scores indicate improved outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in State-Train Anxiety Inventory (STAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-loop tACS', 'description': 'Closed-loop individual alpha tACS daily for five consecutive days.'}], 'classes': [{'title': 'D5-D1', 'categories': [{'measurements': [{'value': '-3.08', 'spread': '10.03', 'groupId': 'OG000'}]}]}, {'title': 'FU1-D1', 'categories': [{'measurements': [{'value': '-5.16', 'spread': '10.35', 'groupId': 'OG000'}]}]}, {'title': 'FU2-D1', 'categories': [{'measurements': [{'value': '-6.16', 'spread': '12.29', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.021', 'groupIds': ['OG000'], 'groupDescription': 'STAI scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 STAI surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': "Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.", 'nonInferiorityComment': 'This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)', 'description': 'Change in STAI from Day 1 (D1) to Day 5 (D5), Day 12 (one week follow-up; FU1), and Day 19 (two week follow-up; FU2); STAI minimum value is 20, maximum value is 80. Higher scores indicate worse outcome. Negative scores indicate improved outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-loop tACS', 'description': 'Closed-loop individual alpha tACS daily for five consecutive days.'}], 'classes': [{'title': 'D5-D1', 'categories': [{'measurements': [{'value': '6.86', 'spread': '12.58', 'groupId': 'OG000'}]}]}, {'title': 'FU1-D1', 'categories': [{'measurements': [{'value': '15.36', 'spread': '11.34', 'groupId': 'OG000'}]}]}, {'title': 'FU2-D1', 'categories': [{'measurements': [{'value': '16.57', 'spread': '13.56', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0005', 'groupIds': ['OG000'], 'groupDescription': 'QIDS scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 QIDS surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)', 'description': 'Change in Q-LES-Q-SF from Day 1 (D1) to Day 5 (D5), Day 12 (i.e., one week follow-up; FU1), and Day 19 (i.e., two week follow-up; FU2); Q-LES-Q-SF minimum value is 14, maximum value is 70. Higher scores indicate better outcome. Negative scores indicate worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Clinical Global Impression Scale (CGI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-loop tACS', 'description': 'Closed-loop individual alpha tACS daily for five consecutive days.'}], 'classes': [{'title': 'Global Improvement at D5', 'categories': [{'measurements': [{'value': '2.56', 'spread': '1.16', 'groupId': 'OG000'}]}]}, {'title': 'Global Improvement at FU2', 'categories': [{'measurements': [{'value': '1.68', 'spread': '0.75', 'groupId': 'OG000'}]}]}, {'title': 'Severity at D1', 'categories': [{'measurements': [{'value': '4.04', 'spread': '0.79', 'groupId': 'OG000'}]}]}, {'title': 'Severity at D5', 'categories': [{'measurements': [{'value': '2.36', 'spread': '1.19', 'groupId': 'OG000'}]}]}, {'title': 'Severity at FU2', 'categories': [{'measurements': [{'value': '1.76', 'spread': '0.93', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0005', 'groupIds': ['OG000'], 'groupDescription': 'CGI severity scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 CGI assessments were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU2', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.'}, {'pValue': '0.006', 'groupIds': ['OG000'], 'groupDescription': 'CGI improvement scores were submitted to a paired t-test to measure difference between the improvement assessment on D5 and the assessment at FU2. Note: D5 CGI assessments were completed prior to receiving the final treatment on D5. Null hypothesis: D5 = FU2', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.'}], 'paramType': 'MEAN', 'timeFrame': 'Severity: {Day 1 (D1), Day 5 (D5) and Day 19 (FU2)}; Global Improvement: {Day 5 (D5) and Day 19 (FU2)}', 'description': 'Change in CGI from Day 1 (D1) to Day 5 (D5) and Day 19 (i.e., two week follow-up; FU2); CGI scale contains two scoring components, 1) Severity of Illness (0-7) and 2) Global Improvement (0-7). Higher scores in component 1 indicate worse symptoms while higher numbers in component 2 indicate worse clinical outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Alpha Oscillation Power', 'timeFrame': '19 days', 'description': 'Change in EEG alpha oscillation power at D1 pre-stimulation, D1 post-stimulation, and FU2.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Quick Inventory of Depressive Symptomatology (QIDS) Over 12 Weeks', 'timeFrame': '89 days', 'description': 'Change in QIDS at four week follow-up (FU3), six week follow-up (FU4), eight week follow-up (FU5), ten week follow-up (FU6), and twelve week follow-up (FU7); minimum value is 0, maximum value is 27. Higher scores indicate worse outcome.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Altman Self-Rating Mania Scale (ASRM) Over 12 Weeks', 'timeFrame': '89 days', 'description': 'Change in ASRM at FU3, FU4, FU5, FU6, and FU7; minimum value is 0, maximum value is 20. Higher scores indicate worse outcome.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Snaith-Hamilton Pleasure Scale (SHAPS) Over 12 Weeks', 'timeFrame': '89 days', 'description': 'Change in SHAPS at FU3, FU4, FU5, FU6, and FU7; minimum value is 0, maximum value is 14. Higher scores indicate worse outcome.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Depression Anxiety and Stress Scale (DASS-42) Over 12 Weeks', 'timeFrame': '89 days', 'description': 'Change in DASS-42 at FU3, FU4, FU5, FU6, and FU7; minimum value is 0, maximum value is 126 with three subscales (0 to 42). Higher scores indicate worse outcome.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in State-Train Anxiety Inventory (STAI) Over 12 Weeks', 'timeFrame': '89 days', 'description': 'Change in STAI at FU3, FU4, FU5, FU6, and FU7; minimum value is 20, maximum value is 80. Higher scores indicate worse outcome.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF)', 'timeFrame': '89 days', 'description': 'Change in Q-LES-Q-SF at FU3, FU4, FU5, FU6, and FU7; minimum value is 14, maximum value is 70. Higher scores indicate better outcome.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'HDRS-17 Change', 'timeFrame': '47 Days', 'description': 'Change in HDRS-17 between six week follow up (FU4) and D1', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Closed-loop tACS', 'description': 'Closed-loop individual alpha tACS daily for five consecutive days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'One participant experienced nausea and vomiting during the first treatment session. These transient symptoms were deemed to be mild and considered unlikely to be related to stimulation by the study clinician since the participant did not disclose an ongoing COVID-19 infection, which included headache, dizziness, and nausea before stimulation onset. Study participation was ended for this participant.', 'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Closed-loop tACS', 'description': 'Closed-loop individual alpha tACS daily for five consecutive days.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.1', 'spread': '15.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Gender nonconforming', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline HDRS-17 Score', 'classes': [{'categories': [{'measurements': [{'value': '17.18', 'spread': '4.19', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline HDRS-17 (Hamilton Depression Rating Scale, 17-item) score on Day 1 (D1) of treatment week prior to receiving treatment; minimum value is 0, maximum value is 52. Higher scores indicate worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline QIDS Score', 'classes': [{'categories': [{'measurements': [{'value': '14.72', 'spread': '2.67', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline QIDS (Quick Inventory of Depressive Symptomatology) score on Day 1 (D1) of treatment week prior to receiving treatment; minimum value is 0, maximum value is 27. Higher scores indicate worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Q-LES-Q-SF Score', 'classes': [{'categories': [{'measurements': [{'value': '37.44', 'spread': '5.12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form) on day 1 (D1); minimum value is 14, maximum value is 70. Higher scores indicate better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline ASRM Score', 'classes': [{'categories': [{'measurements': [{'value': '1.16', 'spread': '1.28', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline ASRM (Altman Self-Rating Mania Scale) on day 1 (D1); minimum value is 0, maximum value is 20. Higher scores indicate worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline SHAPS Score', 'classes': [{'categories': [{'measurements': [{'value': '5.52', 'spread': '3.27', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline SHAPS (Snaith-Hamilton Pleasure Scale) score on day 1 (D1); minimum value is 0, maximum value is 14. Higher scores indicate worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline DASS-42 Score', 'classes': [{'title': 'Overall Score', 'categories': [{'measurements': [{'value': '45.96', 'spread': '14.42', 'groupId': 'BG000'}]}]}, {'title': 'Depression Subscale', 'categories': [{'measurements': [{'value': '23.12', 'spread': '6.31', 'groupId': 'BG000'}]}]}, {'title': 'Anxiety Subscale', 'categories': [{'measurements': [{'value': '6.48', 'spread': '4.09', 'groupId': 'BG000'}]}]}, {'title': 'Stress Subscale', 'categories': [{'measurements': [{'value': '16.36', 'spread': '9.34', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline DASS-42 (Depression, Anxiety, and Stress Scale, 42-item) on day 1 (D1); minimum value is 0, maximum value is 126 with three subscales (0 to 42). Higher scores indicate worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline STAI Score', 'classes': [{'categories': [{'measurements': [{'value': '47.88', 'spread': '10.78', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline STAI (State-Trait Anxiety Inventory (state score)) on day 1 (D1); minimum value is 20, maximum value is 80. Higher scores indicate worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-16', 'size': 1110786, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-21T17:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-Label'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2023-02-24', 'resultsFirstSubmitDate': '2025-04-21', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-12', 'studyFirstPostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Alpha Oscillation Power', 'timeFrame': '19 days', 'description': 'Change in EEG alpha oscillation power at D1 pre-stimulation, D1 post-stimulation, and FU2.'}, {'measure': 'Change in Quick Inventory of Depressive Symptomatology (QIDS) Over 12 Weeks', 'timeFrame': '89 days', 'description': 'Change in QIDS at four week follow-up (FU3), six week follow-up (FU4), eight week follow-up (FU5), ten week follow-up (FU6), and twelve week follow-up (FU7); minimum value is 0, maximum value is 27. Higher scores indicate worse outcome.'}, {'measure': 'Change in Altman Self-Rating Mania Scale (ASRM) Over 12 Weeks', 'timeFrame': '89 days', 'description': 'Change in ASRM at FU3, FU4, FU5, FU6, and FU7; minimum value is 0, maximum value is 20. Higher scores indicate worse outcome.'}, {'measure': 'Change in Snaith-Hamilton Pleasure Scale (SHAPS) Over 12 Weeks', 'timeFrame': '89 days', 'description': 'Change in SHAPS at FU3, FU4, FU5, FU6, and FU7; minimum value is 0, maximum value is 14. Higher scores indicate worse outcome.'}, {'measure': 'Change in Depression Anxiety and Stress Scale (DASS-42) Over 12 Weeks', 'timeFrame': '89 days', 'description': 'Change in DASS-42 at FU3, FU4, FU5, FU6, and FU7; minimum value is 0, maximum value is 126 with three subscales (0 to 42). Higher scores indicate worse outcome.'}, {'measure': 'Change in State-Train Anxiety Inventory (STAI) Over 12 Weeks', 'timeFrame': '89 days', 'description': 'Change in STAI at FU3, FU4, FU5, FU6, and FU7; minimum value is 20, maximum value is 80. Higher scores indicate worse outcome.'}, {'measure': 'Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF)', 'timeFrame': '89 days', 'description': 'Change in Q-LES-Q-SF at FU3, FU4, FU5, FU6, and FU7; minimum value is 14, maximum value is 70. Higher scores indicate better outcome.'}, {'measure': 'HDRS-17 Change', 'timeFrame': '47 Days', 'description': 'Change in HDRS-17 between six week follow up (FU4) and D1'}], 'primaryOutcomes': [{'measure': 'Change in Hamilton Depression Rating Scale 17-item (HDRS-17)', 'timeFrame': 'Day 1 to Day 19 (i.e. 19 days)', 'description': 'Change in HDRS-17 from Day 1 (D1) to Day 19 (i.e., two week follow-up; FU2); HDRS-17 minimum value is 0, maximum value is 52. Higher scores indicate worse outcome. Negative scores indicate improved outcomes.'}], 'secondaryOutcomes': [{'measure': 'Change in Hamilton Depression Rating Scale 17-item (HDRS-17)', 'timeFrame': 'Day 1 to Day 5 (i.e., 5 days)', 'description': 'Change in HDRS-17 from Day 1 (D1) to Day 5 (D5); HDRS-17minimum value is 0, maximum value is 52. Higher scores indicate worse outcome. Negative scores indicate improved outcomes.'}, {'measure': 'Response/Remission of Depression', 'timeFrame': 'Day 5 and Day 19', 'description': 'Number of response/remission rates at Day 5 (D5) and Day 19 (i.e., two week follow-up; FU2). Response defined as \\>=50% reduction in HDRS-17 from D1. Remission defined as HDRS-17 score \\<=7.'}, {'measure': 'Change in Quick Inventory of Depressive Symptomatology (QIDS)', 'timeFrame': 'Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)', 'description': 'Change in QIDS at Day 5 (D5), Day 12 (i.e., one-week follow-up; FU1), and Day 19 (i.e., two-week follow-up; FU2); QIDS minimum value is 0, maximum value is 27. Higher scores indicate worse outcome. Negative scores indicate improved outcome.'}, {'measure': 'Change in Altman Self-Rating Mania Scale (ASRM)', 'timeFrame': 'Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)', 'description': 'Change in ASRM at Day 5 (D5), Day 12 (i.e., one week follow-up; FU1), and Day 19 (i.e., two week follow-up; FU2); ASRM minimum value is 0, maximum value is 20. Higher scores indicate worse outcome. Negative scores indicate improved outcome.'}, {'measure': 'Change in Snaith-Hamilton Pleasure Scale (SHAPS)', 'timeFrame': 'Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)', 'description': 'Change in SHAPS from Day 1 (D1) to Day 5 (D5), Day 12 (i.e., one week follow-up; FU1), and Day 19 (i.e., two week follow-up; FU2); SHAPS minimum value is 0, maximum value is 14. Higher scores indicate worse outcome. Negative scores indicate improved outcome.'}, {'measure': 'Change in Depression Anxiety and Stress Scale (DASS-42)', 'timeFrame': 'Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)', 'description': 'Change in DASS-42 from Day 1 (D1) to Day 5 (D5), Day 12 (i.e., one week follow-up; FU1), and Day 19 (i.e., two week follow-up; FU2); DASS-42 minimum value is 0, maximum value is 126 with three subscales (0 to 42). Higher scores indicate worse outcome. Negative scores indicate improved outcome.'}, {'measure': 'Change in State-Train Anxiety Inventory (STAI)', 'timeFrame': 'Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)', 'description': 'Change in STAI from Day 1 (D1) to Day 5 (D5), Day 12 (one week follow-up; FU1), and Day 19 (two week follow-up; FU2); STAI minimum value is 20, maximum value is 80. Higher scores indicate worse outcome. Negative scores indicate improved outcome.'}, {'measure': 'Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF)', 'timeFrame': 'Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)', 'description': 'Change in Q-LES-Q-SF from Day 1 (D1) to Day 5 (D5), Day 12 (i.e., one week follow-up; FU1), and Day 19 (i.e., two week follow-up; FU2); Q-LES-Q-SF minimum value is 14, maximum value is 70. Higher scores indicate better outcome. Negative scores indicate worse outcome.'}, {'measure': 'Change in Clinical Global Impression Scale (CGI)', 'timeFrame': 'Severity: {Day 1 (D1), Day 5 (D5) and Day 19 (FU2)}; Global Improvement: {Day 5 (D5) and Day 19 (FU2)}', 'description': 'Change in CGI from Day 1 (D1) to Day 5 (D5) and Day 19 (i.e., two week follow-up; FU2); CGI scale contains two scoring components, 1) Severity of Illness (0-7) and 2) Global Improvement (0-7). Higher scores in component 1 indicate worse symptoms while higher numbers in component 2 indicate worse clinical outcomes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Depression', 'Major Depressive Disorder', 'tACS']}, 'referencesModule': {'references': [{'pmid': '30837453', 'type': 'BACKGROUND', 'citation': 'Alexander ML, Alagapan S, Lugo CE, Mellin JM, Lustenberger C, Rubinow DR, Frohlich F. Double-blind, randomized pilot clinical trial targeting alpha oscillations with transcranial alternating current stimulation (tACS) for the treatment of major depressive disorder (MDD). Transl Psychiatry. 2019 Mar 5;9(1):106. doi: 10.1038/s41398-019-0439-0.'}], 'seeAlsoLinks': [{'url': 'https://researchforme.unc.edu/index.php/en/study-details?rcid=4419', 'label': 'Link to more information and study recruitment for interested potential participants.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to study closed-loop transcranial alternating current stimulation (tACS) to determine its effects on symptoms of depression in people with major depressive disorder.', 'detailedDescription': 'The purpose of this clinical trial is to investigate the preliminary efficacy of closed-loop tACS for the treatment of major depressive disorder (MDD) in an open-label pilot study. We will recruit up to 35 participants with unipolar, non-psychotic MDD. Participation will include seven visits, two of them remotely (with an in-person option as needed), and one electronic survey.\n\nPotential participants fill-in an electronic pre-screening form. If potentially eligible, a remote screening visit is performed. If eligible, participants attend five consecutive, daily stimulation sessions. Clinical assessments will be performed at baseline (Day 1 of stimulation, D1), Day five of stimulation (D5), and at their follow-up visit (14 days after the completion of stimulation, FU2) using the Hamilton Depression Rating Scale (HDRS-17).\n\nFor a subset of patients, electroencephalography (EEG) is collected at D1 prior to stimulation and after stimulation and again at FU2.\n\nFor a subset of patients, self-scoring surveys will be sent bi-weekly until 12 weeks after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18-70 years\n* Diagnostic and Statistical Manual, 5th Edition (DSM-5) diagnosis of MDD; unipolar, non-psychotic\n* Hamilton Rating Depression Rating Scale (HRDS-17) score \\>8\n* Low suicide risk as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) triage form (no intent or plan)\n* Capacity to understand all relevant risks and potential benefits of the study (informed consent)\n\nExclusion Criteria:\n\n* DSM-5 diagnosis of severe alcohol use disorder (AUD) within the last 12 months.\n* DSM-5 diagnosis of moderate to severe substance use disorder (excluding tobacco) within the last 12 months.\n* Lifetime history of bipolar disorder, psychotic disorder, schizophrenia, autism\n* Current use of benzodiazepines \\> 20mg diazepam/d equivalent\n* Antidepressant dose change within the last 2 weeks\n* Initiated new antidepressant within the last 4 weeks'}, 'identificationModule': {'nctId': 'NCT05772702', 'acronym': 'CLACS', 'briefTitle': 'Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Depression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Electromedical Products International, Inc.'}, 'officialTitle': 'Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Depression (CLACS): Single-Site Open-Label Pilot Study', 'orgStudyIdInfo': {'id': '22-3094'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Closed-loop tACS', 'description': 'Closed-loop individual alpha tACS daily for five consecutive days.', 'interventionNames': ['Device: Closed-loop tACS']}], 'interventions': [{'name': 'Closed-loop tACS', 'type': 'DEVICE', 'description': 'Individual alpha tACS', 'armGroupLabels': ['Closed-loop tACS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27516', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Center for Neurostimulation', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'David R Rubinow, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Electromedical Products International, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}