Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-02 @ 4:56 AM
Study NCT ID:
NCT06904092
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-01
First Post:
2025-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Mechanisms of TUS on Cognitive Deficits in Schizophrenia: Based on the Hippocampal-Prefrontal Circuit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D003072', 'term': 'Cognition Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2025-03-25', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in associative memory test score', 'timeFrame': 'baseline, 4 weeks and 8 weeks', 'description': 'Change from baseline in the associative memory test score at 4 weeks and 8 weeks.'}], 'secondaryOutcomes': [{'measure': 'Change of information processing speed and attention/vigilance', 'timeFrame': 'baseline, 4 weeks and 8 weeks', 'description': 'Change from baseline in 4 MCCB subtests score at 4 weeks and 8 weeks.'}, {'measure': 'Change of working memory', 'timeFrame': 'baseline, 4 weeks and 8 weeks', 'description': 'Change from baseline in N-back task at 4 weeks and 8 weeks. The outcome measures include accuracy, D-prime value, and reaction time.'}, {'measure': 'Change from baseline in Positive and Negative Syndrome Scale(PANSS)', 'timeFrame': 'baseline, 4 weeks and 8 weeks', 'description': 'Change from baseline in Positive and Negative Syndrome Scale(PANSS) at 4 weeks and 8 weeks. The minimum to maximum value is 30-210. Lower scores mean a better outcome.'}, {'measure': 'Change of CGI score', 'timeFrame': 'baseline, 4 weeks and 8 weeks', 'description': 'Change from baseline in Clinical Global Impression (CGI) at 4 weeks and 8 weeks.'}, {'measure': 'Change from baseline in UCSD Performance-based Skills Assessment-Brief (UPSA-B)', 'timeFrame': 'baseline, 4 weeks and 8 weeks', 'description': 'Change from baseline in UCSD Performance-based Skills Assessment-Brief (UPSA-B) at 4 weeks and 8 weeks.'}, {'measure': 'Change of Multi-modal Brain Neuroimaging in structure', 'timeFrame': 'baseline and 4 weeks', 'description': 'Brain structure data will be acquired.'}, {'measure': 'Change of Multi-modal Brain Neuroimaging in resting- state fMRI', 'timeFrame': 'baseline and 4 weeks', 'description': 'Resting-state fMRI data will be acquired.'}, {'measure': 'Change of Multi-modal Brain Neuroimaging in 1H-MRS', 'timeFrame': 'baseline and 4 weeks', 'description': '1H-MRS data will be acquired.'}, {'measure': 'Change of TEPs', 'timeFrame': 'baseline and 4 weeks', 'description': 'TMS-evoked potentials (TEPs) from target regions will be measured in participants at baseline, after a single TUS intervention, and at 4 weeks. The study aimed to clarify the effects of TUS treatment on the components of TEPs in individuals with schizophrenia, as well as the association between changes in TEP components and cognitive deficits.'}, {'measure': 'Change of 64 channels EEG', 'timeFrame': 'baseline and 4 weeks', 'description': '64 channels EEG data will be acquired.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Schizophrenia; Cognitive Deficit; Transcranial Ultrasound Stimulation; Hippocampus- Prefrontal Circuit'], 'conditions': ['Cognitive Deficit in Schizophrenia']}, 'descriptionModule': {'briefSummary': 'Cognitive deficit is a core symptom of schizophrenia related to poorer functional outcome. Prior studies indicated that abnormalities in the hippocampus-prefrontal circuit and glutamate/GABA imbalances may lead to cognitive deficits. Based on the current background and our previous studies, it has been proved that TUS can modulate neural excitability and plasticity in the hippocampus. In this double-blind, randomized study, the efficacy of different treatment options and mechanisms of TUS on cognitive deficits will be investigated.', 'detailedDescription': 'Cognitive deficit is a core symptom of schizophrenia related to poorer functional outcome which remains largely treatment refractory. Prior studies indicated that abnormalities in the hippocampus-prefrontal circuit and glutamate/GABA imbalances may be the root causes of cognitive deficits. Transcranial ultrasound stimulation (TUS), an emerging non-invasive neuromodulation technique with deep penetration ability, can modulate neural excitability and plasticity in the hippocampus. This is a 4-week double-blind randomized trial of TUS for cognitive deficits in schizophrenia, with either left hippocampus or left dorsolateral prefrontal cortex (DLPFC) or both targeted. This study aims to determine the efficacy of TUS and to reveal its underlying neural mechanism, especially with the hippocampus-prefrontal circuit, by means of TUS, as to assess cortical inhibition and excitability, EEG source imaging, and multi-model MRI. Neuropsychological assessments will also be conducted to develop the optimized treatment strategy. The study points to a novel and promising therapeutic neuromodulation approach that may improve the functional outcome of schizophrenia, which has been the main cause of mental disability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meet the DSM-5 diagnostic criteria for schizophrenia ;\n* Age18-50, right-handed, Han nationality;\n* Presence of cognitive deficit: defined as d' value \\<0.5 in associative memory test;\n* Be in a stable condition, received second-generation antipsychotics for at least 4 weeks or more;\n* Written informed consent;\n\nExclusion Criteria:\n\n* Current or past neurological illness, severe physical diseases, substance abuse or alcohol dependence, mental retardation, pregnancy or lactation;\n* Uncooperative or risky patients with high excitement, stupor, disorder of words and deeds, negative suicide, etc.;\n* History of MECT or other physical therapy within 6 months;\n* History of epilepsy, or epileptic waves on the baseline EEG;\n* Ruled out share antiepileptic drugs (carbamazepine, valproic acid salt) or larger doses of benzodiazepine drugs (diazepam \\> 10mg/day, clonazepam \\> 2mg/day etc.), if necessary, remain unchanged during the course of treatment;\n* Contraindications to TUS and MRI are present."}, 'identificationModule': {'nctId': 'NCT06904092', 'briefTitle': 'Efficacy and Mechanisms of TUS on Cognitive Deficits in Schizophrenia: Based on the Hippocampal-Prefrontal Circuit', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Mental Health Center'}, 'officialTitle': 'Efficacy and Mechanisms of Transcranial Ultrasound Stimulation (TUS) on Cognitive Deficits in Schizophrenia：based on the Hippocampal-Prefrontal Circuit', 'orgStudyIdInfo': {'id': '82371504'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'single target group : left DLPFC', 'description': '35 eligible patients will be treated with active TUS for 4 weeks on the left DLPFC', 'interventionNames': ['Device: Transcranial ultrasound stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'single target group : left hippocampus', 'description': '35 eligible patients will be treated with active TUS for 4 weeks on the left hippocampus', 'interventionNames': ['Device: Transcranial ultrasound stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'both-target group : left DLPFC and left hippocampus', 'description': '35 eligible patients will be treated with active TUS for 4 weeks on the left DLPFC and left hippocampus', 'interventionNames': ['Device: Transcranial ultrasound stimulation']}], 'interventions': [{'name': 'Transcranial ultrasound stimulation', 'type': 'DEVICE', 'description': 'The TUS was administered using Transcranial Ultrasound Stimulator UNS-III (model UNS-III), which has passed the safety test for medical electrical equipment (GB9706.1-2007). Transcranial ultrasound stimulation on the target. Duration:20 days (workdays for four consecutive weeks).', 'armGroupLabels': ['both-target group : left DLPFC and left hippocampus', 'single target group : left DLPFC', 'single target group : left hippocampus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Dengtang LIU', 'role': 'CONTACT', 'email': 'liudengtang@smhc.org.cn', 'phone': '021-34773434'}], 'facility': 'Shanghai Mental Health Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Dengtang LIU', 'role': 'CONTACT', 'email': 'liudengtang@smhc.org.cn', 'phone': '021-34773434'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Mental Health Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}