Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 11:45 PM
Study NCT ID:
NCT05746494
Status:
COMPLETED
Last Update Posted:
2025-02-26
First Post:
2023-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Efficacy of Neural Stimulation in Individuals With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'linlin.fan@utdallas.edu; linlinfan@um.edu.mo', 'phone': '+(853) 8822 4226', 'title': 'Dr. Linlin Fan', 'organization': 'University of Texas at Dallas'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The inherent limitations of the assessment tools for measuring social functioning in the lab may have impacted the findings.'}}, 'adverseEventsModule': {'timeFrame': 'Immediately after the stimulation visit, up to 24 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Active Visit', 'description': 'Active anodal tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Visit', 'description': 'Sham tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The State Social Paranoia Scale (SSPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Visit', 'description': 'Performance at the active visit'}, {'id': 'OG001', 'title': 'Sham Visit', 'description': 'Performance at the sham visit'}], 'classes': [{'categories': [{'measurements': [{'value': '9.72', 'spread': '14.61', 'groupId': 'OG000'}, {'value': '3.90', 'spread': '11.56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.023', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Omnibus analysis'}], 'paramType': 'MEAN', 'timeFrame': 'The assessment was completed before the stimulation and 30 minutes after completion of the active/sham stimulation', 'description': 'Paranoid ideation was measured by the State Social Paranoia Scale (SSPS). Participants indicated how much they agree with each of 20 statements (e.g., "Someone was hostile towards me", "Someone was trying to isolate me") using a 5-point Likert scale (1 = do not agree, 5 = totally agree). Scores range from 20-100, and higher scores represent higher state paranoid ideation.', 'unitOfMeasure': 'The change score of SSPS (pre - post)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ecological Momentary Assessment (EMA)-Based Paranoia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EMA-baseline', 'description': 'EMA-baseline'}, {'id': 'OG001', 'title': 'EMA-active', 'description': 'EMA-active'}, {'id': 'OG002', 'title': 'EMA-sham', 'description': 'EMA-sham'}], 'classes': [{'categories': [{'measurements': [{'value': '3.78', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '3.61', 'spread': '0.91', 'groupId': 'OG001'}, {'value': '3.96', 'spread': '1.85', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.042', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Multilevel Modeling', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Omnibus analysis'}], 'paramType': 'MEAN', 'timeFrame': 'Change in daily paranoia feelings was assessed from the pre-stimulation EMA period (7 days before the stimulation visit) to the post-stimulation EMA period (7 days after the stimulation visit)', 'description': 'Paranoid ideation was measured by Ecological Momentary Assessment (EMA), which involved questions about feelings of paranoia in daily life. The paranoia-related question is as follows: "Since the past alarm, how much have you had thoughts that you really can\'t trust other people?" The score for this item ranges from 1 to 7, with a higher score indicating a higher level of paranoid thinking.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 47 (out of 50) participants completed this measure.'}, {'type': 'PRIMARY', 'title': 'Birchwood Social Functioning Scale (SFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Visit', 'description': 'Performance at the active visit'}, {'id': 'OG001', 'title': 'Sham Visit', 'description': 'Performance at the sham visit'}], 'classes': [{'categories': [{'measurements': [{'value': '114.21', 'spread': '22.35', 'groupId': 'OG000'}, {'value': '114.59', 'spread': '27.54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.980', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Omnibus analysis'}], 'paramType': 'MEAN', 'timeFrame': 'The assessment was completed 30 minutes after completion of the active/sham stimulation', 'description': 'Social functioning was measured by the Birchwood Social Functioning Scale (SFS). This scale measures social adjustment based on self-reports (4- or 5-point scales), with higher total scores indicating better social functioning (range = 0-223).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ecological Momentary Assessment (EMA)-Based Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EMA-baseline', 'description': 'EMA-baseline'}, {'id': 'OG001', 'title': 'EMA-active', 'description': 'EMA-active'}, {'id': 'OG002', 'title': 'EMA-sham', 'description': 'EMA-sham'}], 'classes': [{'title': 'Social interaction frequency', 'categories': [{'measurements': [{'value': '0.97', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '0.83', 'groupId': 'OG001'}, {'value': '0.92', 'spread': '0.90', 'groupId': 'OG002'}]}]}, {'title': 'Social interaction motivation and experience', 'categories': [{'measurements': [{'value': '3.74', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '4.08', 'spread': '1.68', 'groupId': 'OG001'}, {'value': '3.71', 'spread': '1.62', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.010', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Multilevel Modeling', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Omnibus analysis'}], 'paramType': 'MEAN', 'timeFrame': 'Change in daily interactions was assessed from the pre-stimulation EMA period (7 days before the stimulation visit) to the post-stimulation EMA period (7 days after the stimulation visit)', 'description': 'Social functioning was measured by Ecological Momentary Assessment (EMA) (i.e., questions about daily interactions with others). Two subscores were generated: social interaction frequency (score ranges from 0-5, a higher score indicates more frequent social interactions), social interaction motivation and experience (scores range from 1-7, a higher score indicates higher motivations to interact with others and better experiences during these interactions).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 47 (out of 50) participants completed this measure.'}, {'type': 'SECONDARY', 'title': 'The Trustworthiness Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Visit', 'description': 'Performance at the active visit'}, {'id': 'OG001', 'title': 'Sham Visit', 'description': 'Performance at the sham visit'}], 'classes': [{'categories': [{'measurements': [{'value': '0.07', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.99', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.064', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Omnibus analysis'}], 'paramType': 'MEAN', 'timeFrame': 'The assessment was completed 30 minutes after completion of the active/sham stimulation', 'description': 'Paranoid ideation was measured by the Trustworthiness Task. This task requires participants to indicate how much they trust each of 60 grayscale facial stimuli along a 7-point Likert scale (-3 = very untrustworthy, 3 = very trustworthy). Total scores were calculated by averaging across responses and hence varied from -3 to +3, with higher values indicating a greater tendency to trust others.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Scrambled-sentences Task (SST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Visit', 'description': 'Performance at the active visit'}, {'id': 'OG001', 'title': 'Sham Visit', 'description': 'Performance at the sham visit'}], 'classes': [{'categories': [{'measurements': [{'value': '0.46', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '0.49', 'spread': '0.28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.306', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Omnibus analysis'}], 'paramType': 'MEAN', 'timeFrame': 'The assessment was completed 30 minutes after completion of the active/sham stimulation', 'description': 'Paranoid ideation was measured by the Scrambled-sentences task (SST). This task measures the level of paranoia by asking participants to create sentences of either paranoid or nonparanoid meanings, with a greater percentage indicating a higher level of paranoid interpretation bias (range = 0-1).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 49 (out of 50) participants completed this task.'}, {'type': 'SECONDARY', 'title': 'The Ambiguous Intentions Hostility Questionnaire (AIHQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Visit', 'description': 'Performance at the active visit'}, {'id': 'OG001', 'title': 'Sham Visit', 'description': 'Performance at the sham visit'}], 'classes': [{'title': 'AIHQ (blame)', 'categories': [{'measurements': [{'value': '8.28', 'spread': '3.07', 'groupId': 'OG000'}, {'value': '8.89', 'spread': '3.22', 'groupId': 'OG001'}]}]}, {'title': 'AIHQ (hostility)', 'categories': [{'measurements': [{'value': '2.09', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '2.35', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'AIHQ (aggression)', 'categories': [{'measurements': [{'value': '1.75', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '1.78', 'spread': '0.39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.041', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Omnibus analysis'}], 'paramType': 'MEAN', 'timeFrame': 'The assessment was completed 30 minutes after completion of the active/sham stimulation', 'description': 'Paranoid ideation was measured by the Ambiguous Intentions Hostility Questionnaire (AIHQ). Three subscores were generated: AIHQ (blame) (ranging from 3-16, with a higher score indicating a higher level of blaming tendency), AIHQ (hostility) (ranging from 1-5, with a higher score indicating a higher level of hostility), AIHQ (aggression) (ranging from 1-5, with a higher score indicating a higher level of aggression).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Hostility Scale of the Personality Inventory for DSM-5 (PID-5-HS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Visit', 'description': 'Performance at the active visit'}, {'id': 'OG001', 'title': 'Sham Visit', 'description': 'Performance at the sham visit'}], 'classes': [{'categories': [{'measurements': [{'value': '9.42', 'spread': '7.56', 'groupId': 'OG000'}, {'value': '11.30', 'spread': '7.57', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Omnibus analysis'}], 'paramType': 'MEAN', 'timeFrame': 'The assessment was completed 30 minutes after completion of the active/sham stimulation', 'description': 'Paranoid ideation was measured by the Hostility Scale of the Personality Inventory for DSM-5 (PID-5-HS). PID-5-HS contains 10 self-report items assessing pathological hostility. A total score (range from 0-30) was generated to reflect overall hostility level, with higher total scores indicating more hostility.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Anodal tDCS First, Then Sham tDCS', 'description': 'Active anodal tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing; Washout (about 1 week); sham stimulation (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing.\n\ntDCS: active anodal tDCS and sham tDCS'}, {'id': 'FG001', 'title': 'Sham tDCS First, Then Active Anodal tDCS', 'description': 'Sham tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing; Washout (about 1 week); Active anodal tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing Intervention.\n\ntDCS: active anodal tDCS and sham tDCS'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 50 participants were enrolled and eventually completing the whole procedure.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Anodal tDCS First, Then Sham tDCS', 'description': 'Active anodal tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing; Washout (about 1 week); sham stimulation (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing.\n\ntDCS: active anodal tDCS and sham tDCS'}, {'id': 'BG001', 'title': 'Sham tDCS First, Then Active Anodal tDCS', 'description': 'Sham tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing; Washout (about 1 week); Active anodal tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing Intervention.\n\ntDCS: active anodal tDCS and sham tDCS'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.08', 'spread': '10.24', 'groupId': 'BG000'}, {'value': '45.46', 'spread': '11.30', 'groupId': 'BG001'}, {'value': '44.74', 'spread': '10.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (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': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', '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': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Handedness', 'classes': [{'title': 'right-handed', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'left-handed', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Years of education', 'classes': [{'categories': [{'measurements': [{'value': '12.42', 'spread': '2.08', 'groupId': 'BG000'}, {'value': '13.31', 'spread': '2.26', 'groupId': 'BG001'}, {'value': '12.85', 'spread': '2.20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'The Wide Range Achievement Test-Reading recognition subtest 4 (WRAT-4)', 'classes': [{'categories': [{'measurements': [{'value': '96.11', 'spread': '9.76', 'groupId': 'BG000'}, {'value': '94.08', 'spread': '15.02', 'groupId': 'BG001'}, {'value': '95.14', 'spread': '12.47', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This scale measures the Intelligence Quotient (IQ). A total final standardized score (adjusted by age) is computed. The range of this total score is from 55 to 145. A higher total score indicates a higher IQ and suggests that the participant is more intelligent.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Chlorpromazine (CPZ)-equivalent', 'classes': [{'categories': [{'measurements': [{'value': '468.63', 'spread': '1150.45', 'groupId': 'BG000'}, {'value': '396.32', 'spread': '520.71', 'groupId': 'BG001'}, {'value': '433.92', 'spread': '896.59', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This measures the dosage of antipsychotic medications that the participant is taking. A total final score is computed. The range of this total score is from 0 to unlimited. A higher score indicates a higher dosage of antipsychotic medications.', 'unitOfMeasure': 'mg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diagnoses', 'classes': [{'title': 'SCZ', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'SCZ-A', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Two types of diagnoses were included in this study, including schizophrenia (SCZ) and schizoaffective disorder (SCZ-A). Diagnoses were determined via Mini International Neuropsychiatric Interview (MINI) and Structured Clinical Interview for DSM Disorders-Psychosis Module (SCID-P).', 'unitOfMeasure': 'participants'}, {'title': 'Current/recent paranoia', 'classes': [{'title': 'Current', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Recent', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-11-19', 'size': 994652, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-19T01:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Participants will complete active and sham simulation sessions in a randomized, counterbalanced order about one week apart.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2023-02-02', 'resultsFirstSubmitDate': '2024-11-19', 'studyFirstSubmitQcDate': '2023-02-24', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-03', 'studyFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The State Social Paranoia Scale (SSPS)', 'timeFrame': 'The assessment was completed before the stimulation and 30 minutes after completion of the active/sham stimulation', 'description': 'Paranoid ideation was measured by the State Social Paranoia Scale (SSPS). Participants indicated how much they agree with each of 20 statements (e.g., "Someone was hostile towards me", "Someone was trying to isolate me") using a 5-point Likert scale (1 = do not agree, 5 = totally agree). Scores range from 20-100, and higher scores represent higher state paranoid ideation.'}, {'measure': 'Ecological Momentary Assessment (EMA)-Based Paranoia', 'timeFrame': 'Change in daily paranoia feelings was assessed from the pre-stimulation EMA period (7 days before the stimulation visit) to the post-stimulation EMA period (7 days after the stimulation visit)', 'description': 'Paranoid ideation was measured by Ecological Momentary Assessment (EMA), which involved questions about feelings of paranoia in daily life. The paranoia-related question is as follows: "Since the past alarm, how much have you had thoughts that you really can\'t trust other people?" The score for this item ranges from 1 to 7, with a higher score indicating a higher level of paranoid thinking.'}, {'measure': 'Birchwood Social Functioning Scale (SFS)', 'timeFrame': 'The assessment was completed 30 minutes after completion of the active/sham stimulation', 'description': 'Social functioning was measured by the Birchwood Social Functioning Scale (SFS). This scale measures social adjustment based on self-reports (4- or 5-point scales), with higher total scores indicating better social functioning (range = 0-223).'}, {'measure': 'Ecological Momentary Assessment (EMA)-Based Social Functioning', 'timeFrame': 'Change in daily interactions was assessed from the pre-stimulation EMA period (7 days before the stimulation visit) to the post-stimulation EMA period (7 days after the stimulation visit)', 'description': 'Social functioning was measured by Ecological Momentary Assessment (EMA) (i.e., questions about daily interactions with others). Two subscores were generated: social interaction frequency (score ranges from 0-5, a higher score indicates more frequent social interactions), social interaction motivation and experience (scores range from 1-7, a higher score indicates higher motivations to interact with others and better experiences during these interactions).'}], 'secondaryOutcomes': [{'measure': 'The Trustworthiness Task', 'timeFrame': 'The assessment was completed 30 minutes after completion of the active/sham stimulation', 'description': 'Paranoid ideation was measured by the Trustworthiness Task. This task requires participants to indicate how much they trust each of 60 grayscale facial stimuli along a 7-point Likert scale (-3 = very untrustworthy, 3 = very trustworthy). Total scores were calculated by averaging across responses and hence varied from -3 to +3, with higher values indicating a greater tendency to trust others.'}, {'measure': 'The Scrambled-sentences Task (SST)', 'timeFrame': 'The assessment was completed 30 minutes after completion of the active/sham stimulation', 'description': 'Paranoid ideation was measured by the Scrambled-sentences task (SST). This task measures the level of paranoia by asking participants to create sentences of either paranoid or nonparanoid meanings, with a greater percentage indicating a higher level of paranoid interpretation bias (range = 0-1).'}, {'measure': 'The Ambiguous Intentions Hostility Questionnaire (AIHQ)', 'timeFrame': 'The assessment was completed 30 minutes after completion of the active/sham stimulation', 'description': 'Paranoid ideation was measured by the Ambiguous Intentions Hostility Questionnaire (AIHQ). Three subscores were generated: AIHQ (blame) (ranging from 3-16, with a higher score indicating a higher level of blaming tendency), AIHQ (hostility) (ranging from 1-5, with a higher score indicating a higher level of hostility), AIHQ (aggression) (ranging from 1-5, with a higher score indicating a higher level of aggression).'}, {'measure': 'The Hostility Scale of the Personality Inventory for DSM-5 (PID-5-HS)', 'timeFrame': 'The assessment was completed 30 minutes after completion of the active/sham stimulation', 'description': 'Paranoid ideation was measured by the Hostility Scale of the Personality Inventory for DSM-5 (PID-5-HS). PID-5-HS contains 10 self-report items assessing pathological hostility. A total score (range from 0-30) was generated to reflect overall hostility level, with higher total scores indicating more hostility.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Schizo Affective Disorder']}, 'referencesModule': {'references': [{'pmid': '39855408', 'type': 'DERIVED', 'citation': 'Fan L, Carrico S, Zhu Y, Ackerman RA, Pinkham AE. Transcranial Direct Current Stimulation Improves Paranoia and Social Functioning in Schizophrenia: A Randomized Clinical Trial. Biol Psychiatry. 2025 Jul 15;98(2):135-143. doi: 10.1016/j.biopsych.2025.01.011. Epub 2025 Jan 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to understand the relationship between psychotic symptoms and social functioning in individuals with schizophrenia spectrum disorders. Our goal is to determine whether stimulating the brain using transcranial Direct Current Stimulation (tDCS) can improve symptoms and daily functioning.', 'detailedDescription': 'Paranoid ideation is a common delusion experienced by individuals with schizophrenia spectrum disorders (SSD) that negatively impacts social interactions and quality of life. Therefore, efforts to reduce paranoid thinking via neuromodulation techniques \\[e.g., transcranial direct current stimulation (tDCS)\\] are in development, with amygdala-prefrontal cortex (PFC) circuits targeted as critical components of the neural mechanisms underlying paranoia.\n\nThis project aims to alleviate paranoia and improve social functioning in individuals with SSD by implementing tDCS to ventrolateral PFC. A double-blind, within-subjects, crossover design will be used to compare the effects of active vs. sham tDCS. Ecological Momentary Assessments (EMA) will also be utilized to quantify any delayed stimulation effects in daily social interactions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age = 18-64\n* Diagnosed with schizophrenia or schizoaffective disorder\n* Having current (in the past week) or recent (in the past month) paranoia\n\nExclusion Criteria:\n\n* Presence or history of a pervasive developmental disorder or mental retardation as defined by IQ \\< 70\n* Presence or history of neurological or medical disorders that contraindicate neural stimulation (e.g. presence or history of epilepsy, seizures, etc.)\n* Demonstrating sensory limitations, including uncorrectable visual or hearing impairments that interfere with assessment\n* History of electroconvulsive therapy\n* Lack of proficiency in English\n* Substance use disorder not in remission in the past 6 months\n* Any implanted devices such as pace maker, neurostimulator\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05746494', 'briefTitle': 'The Efficacy of Neural Stimulation in Individuals With Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas at Dallas'}, 'officialTitle': 'The Efficacy of Neural Stimulation in Individuals With Schizophrenia', 'orgStudyIdInfo': {'id': '22-630'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active anodal tDCS first, then Sham tDCS', 'description': 'Active anodal tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing; Washout (about 1 week); sham stimulation (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing.', 'interventionNames': ['Device: tDCS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS first, then Active anodal tDCS', 'description': 'Sham tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing; Washout (about 1 week); Active anodal tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing Intervention.', 'interventionNames': ['Device: tDCS']}], 'interventions': [{'name': 'tDCS', 'type': 'DEVICE', 'description': 'active anodal tDCS and sham tDCS', 'armGroupLabels': ['Active anodal tDCS first, then Sham tDCS', 'Sham tDCS first, then Active anodal tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75080', 'city': 'Richardson', 'state': 'Texas', 'country': 'United States', 'facility': 'The Unversity of Texas at Dallas', 'geoPoint': {'lat': 32.94818, 'lon': -96.72972}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas at Dallas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amy Pinkham, PhD', 'investigatorAffiliation': 'The University of Texas at Dallas'}}}}