Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2025-12-27 @ 9:54 AM
Study NCT ID:
NCT07074704
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-24
First Post:
2025-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
tACS to Improve Negative Symptoms & Cognition in Long-term Hospitalized Schizophrenia Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-06-04', 'size': 298364, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-30T19:38', 'hasProtocol': True}, {'date': '2025-06-04', 'size': 109602, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-06-30T19:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-19', 'studyFirstSubmitDate': '2025-06-23', 'studyFirstSubmitQcDate': '2025-07-10', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eye Tracking', 'timeFrame': 'Day 1 before tACS intervention', 'description': 'Binocular saccade amplitude and direction'}, {'measure': 'Eye Tracking', 'timeFrame': 'Day 1 after tACS intervention', 'description': 'Binocular saccade amplitude and direction'}, {'measure': 'EEG', 'timeFrame': 'Day 1 before tACS intervention', 'description': 'resting EEG power spectrum'}, {'measure': 'EEG', 'timeFrame': 'Day 1 after tACS intervention', 'description': 'resting EEG power spectrum'}, {'measure': 'Brief Negative Symptom Scale (Bnss)', 'timeFrame': 'Day 1 before tACS intervention', 'description': 'The Brief Negative Symptom Scale (BNSS) ranges from 0 to 78, with higher scores indicating more severe negative symptoms.'}, {'measure': 'Brief Negative Symptom Scale (Bnss)', 'timeFrame': 'Day 4 after tACS intervention', 'description': 'The Brief Negative Symptom Scale (BNSS) ranges from 0 to 78, with higher scores indicating more severe negative symptoms.'}, {'measure': 'MATRICS Consensus Cognitive Battery，MCCB', 'timeFrame': 'Day 1 before tACS intervention', 'description': 'The MATRICS Consensus Cognitive Battery (MCCB) does not have a fixed total score range, as it consists of multiple tests assessing different cognitive domains. Each domain score is standardized as a T-score, typically ranging from approximately 0 to 100, with higher scores indicating better cognitive performance.'}, {'measure': 'MATRICS Consensus Cognitive Battery，MCCB', 'timeFrame': 'Day 4 after tACS intervention', 'description': 'The MATRICS Consensus Cognitive Battery (MCCB) does not have a fixed total score range, as it consists of multiple tests assessing different cognitive domains. Each domain score is standardized as a T-score, typically ranging from approximately 0 to 100, with higher scores indicating better cognitive performance.'}, {'measure': 'The Clinical Assessment Interview Scale', 'timeFrame': 'Day 1 before tACS intervention', 'description': 'The Clinical Assessment Interview Scale for Negative Symptoms (CAINS) ranges from 0 to 52 , with higher scores indicating more severe negative symptoms.'}, {'measure': 'The Clinical Assessment Interview Scale', 'timeFrame': 'Day 4 after tACS intervention', 'description': 'The Clinical Assessment Interview Scale for Negative Symptoms (CAINS) ranges from 0 to 52 , with higher scores indicating more severe negative symptoms.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Negative Symptoms in Schizophrenia', 'Cognition Function']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the efficacy of transcranial alternating current stimulation (tACS) on negative symptoms and cognitive function in long-term hospitalized patients with schizophrenia. At the same time, this study will explore the potential impact of relevant biomarkers and genetic factors on the efficacy of tACS intervention.', 'detailedDescription': '1. Research purpose (1) This study aims to explore the synergistic therapeutic effect of tACS on negative symptoms and cognitive function in long-term hospitalized schizophrenia patients; (2) Using emotion-induced EEG activity in a virtual reality context as a biomarker, analyze its correlation with the clinical efficacy of tACS.\n2. Expected results (1) It is confirmed that tACS can improve negative symptoms and cognitive function in long-term hospitalized schizophrenia patients; (2) Biomarkers can be used to predict the efficacy of tACS in improving negative symptoms and cognitive function in long-term hospitalized schizophrenia patients, and guide clinical precision application.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria for long-term hospitalized schizophrenia patients:\n\n 1. Diagnosed with DSM-5 schizophrenia and hospitalized for more than half a year\n 2. Aged between 18 and 65 years old\n 3. Willing to participate in the study and sign the informed consent\n 4. Stable condition, PANSS total score changed less than 15% at least 2 months before the study.\n 5. Education level above primary school\n 6. Normal vision or normal after correction\n\nInclusion criteria for normal control group:\n\n1. No diagnosed mental illness\n2. Aged between 18 and 65 years old\n3. Willing to participate in the study and sign the informed consent\n4. Education level above primary school\n5. Normal vision or normal after correction\n6. Residents living in Pudong community\n\nExclusion Criteria:\n\nExclusion criteria for long-term hospitalization of schizophrenia patients:\n\n1. Combined diagnosis of other mental illnesses in DSM-5\n2. History of severe neurological diseases, epilepsy, craniocerebral trauma, etc.\n3. Severe organic diseases of the heart, liver, kidney and other organs that are unstable\n4. Infectious skin diseases\n5. Use of other drugs that affect the results during the study, such as benzodiazepines, non-benzodiazepine sedatives, and psychostimulants\n6. Pregnant or lactating women\n7. Patients with claustrophobia\n8. Patients with alcohol, drugs Abuse history\n9. Patients who have received TACS treatment in the past and have no effect or intolerance\n\nExclusion criteria for normal control group:\n\n1. Patients with a history of severe neurological diseases, epilepsy, craniocerebral trauma, etc.\n2. Patients with severe organic diseases that cause instability of organs such as heart, liver, and kidney\n3. Patients with infectious skin diseases\n4. During the study, drugs that affect the results were used in combination, such as benzodiazepines, non-benzodiazepine sedatives, and psychostimulants\n5. Pregnant or lactating women\n6. Patients with claustrophobia\n7. Patients with a history of alcohol and drug abuse -'}, 'identificationModule': {'nctId': 'NCT07074704', 'briefTitle': 'tACS to Improve Negative Symptoms & Cognition in Long-term Hospitalized Schizophrenia Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Tongji University'}, 'officialTitle': 'Transcranial Alternating Current Stimulation (tACS) as an Augmentation Treatment for Negative Symptoms and Cognitive Deficits in Long-term Hospitalized Schizophrenia Patients', 'orgStudyIdInfo': {'id': 'PDJWWLZL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'TACS sham stimulation group', 'description': 'The intervention lasted for 10 days, with tACS stimulation performed twice a day for 40 minutes each time, using a current of 0 mA.', 'interventionNames': ['Device: Sham Comparison']}, {'type': 'EXPERIMENTAL', 'label': 'tACS Real stimulation group', 'description': 'The intervention lasted for 10 days, with tACS stimulation performed twice a day for 40 minutes each time, using a current of 15 mA.', 'interventionNames': ['Device: Hi-tACS']}], 'interventions': [{'name': 'Hi-tACS', 'type': 'DEVICE', 'description': 'Sham tACS intervention (0 mA) Twice a day, 40 min each time, for 10 days tACS intervention (15 mA) Twice a day, 40 minutes each time, for 10 days', 'armGroupLabels': ['tACS Real stimulation group']}, {'name': 'Sham Comparison', 'type': 'DEVICE', 'description': 'Sham tACS intervention (0 mA) Twice a day, 40 min each time, for 10 days tACS intervention (15 mA) Twice a day, 40 minutes each time, for 10 days', 'armGroupLabels': ['TACS sham stimulation group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Pudong New Area Mental Health Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Weiqing Liu', 'investigatorAffiliation': 'Tongji University'}}}}