[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557786":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":53,"centralContacts":57,"locations":66,"responsibleParty":83,"collaborators":86,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":34,"eligibilityCriteria":107,"healthyVolunteers":108,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":34,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":122,"overallStatus":69,"whyStopped":34,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Beth Israel Deaconess Medical Center","OTHER",[8,14,20,25,30],{"label":9,"type":10,"description":11,"interventionNames":12},"CHR with mb-rt-fMRI-NFB Group","EXPERIMENTAL","This CHR group will receive experimental treatment via mb-rt-fMRI-NFB, in a targeted frontal lobe region including the dorsolateral prefrontal cortex (DLPFC).",[13],"Device: Mb-rt-fMRI-NFB",{"label":15,"type":16,"description":17,"interventionNames":18},"CHR with sham mb-rt-fMRI-NFB Group","SHAM_COMPARATOR","This CHR group will receive treatment via mb-rt-fMRI-NFB, but in a different, uninvolved brain region",[19],"Device: Sham mb-rt-fMRI-NFB",{"label":21,"type":10,"description":22,"interventionNames":23},"CHR with rTMS Group","This CHR group will receive experimental treatment via rTMS, along a targeted neural pathway extending from the cerebellum to the midbrain to the dorsolateral prefrontal cortex (DLPFC)",[24],"Device: rTMS",{"label":26,"type":16,"description":27,"interventionNames":28},"CHR with sham rTMS Group","This CHR group will receive treatment via rTMS, but in a different, uninvolved brain region",[29],"Device: Sham rTMS",{"label":31,"type":32,"description":33,"interventionNames":34},"Healthy Control Group","NO_INTERVENTION","The healthy control group will not receive any treatment, but will be used as a comparison for the 2 experimental and 2 sham groups.",null,[36,41,45,49],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":34},"DEVICE","Mb-rt-fMRI-NFB","The MRI and TMS interventions described below will yield measures of change in the targeted brain regions in post- relative to pre- intervention comparisons. These change measures will be compared relative to changes in the sham\u002Fcontrol group and the HC group. Furthermore, they will be compared to HC to assess improvement or normalization of brain function in the targeted brain regions. In addition, the investigators will examine treatment effects on traditional biomarkers that are likely to be impacted by such interventions: ERP, NP and NLP measures. Here, mindfulness meditation practiced during a real-time fMRI NFB session will be used to bring connectivity changes to brain structures involved in positive psychiatric symptoms (e.g. attenuated psychotic symptoms) in order to to reduce them.",[9],{"type":37,"name":42,"description":43,"armGroupLabels":44,"otherNames":34},"Sham mb-rt-fMRI-NFB","Individuals with CHR who are randomly assigned to this arm will receive mb-rt-fMRI-NFB, as do the experimental group, but it will be aimed at a motor cortex location that is not part of the prefrontal neural networks targeted in the experimental group.",[15],{"type":37,"name":46,"description":47,"armGroupLabels":48,"otherNames":34},"rTMS","In previous work, the investigators used a multivariate pattern analysis to identify functional connectivity correlates of negative symptom severity in a schizophrenia (SZ) group. DLPFC-cerebellum hypo-connectivity was strongly correlated with negative symptoms. In a separate SZ cohort, the investigators used rTMS targeting the cerebellum to manipulate this circuit. The rTMS-induced increase in functional connectivity in a cerebellar-midbrain-DLPFC circuit was strongly linked to negative symptom severity reduction. Furthermore, individuals varied in the degree of change in functional connectivity in response to rTMS. This variation strongly predicted variation in post-rTMS symptom severity. The investigators predict that rTMS based intervention, but not sham rTMS, will similarly impact the cerebellar-midbrain-dorsolateral prefrontal cortex (DLPFC) network in the CHR group receiving real but not sham rTMS.",[21],{"type":37,"name":50,"description":51,"armGroupLabels":52,"otherNames":34},"Sham rTMS","Individuals with CHR who are randomly assigned to this arm will receive rTMS, as do the experimental group, but it will be aimed at a motor cortex location that is not part of the prefrontal neural networks targeted in the experimental group.",[26],[54],{"name":55,"affiliation":5,"role":56},"William S Stone, Ph.D.","PRINCIPAL_INVESTIGATOR",[58,62],{"name":55,"role":59,"phone":60,"phoneExt":34,"email":61},"CONTACT","5087402050","wstone@bidmc.harvard.edu",{"name":63,"role":59,"phone":64,"phoneExt":34,"email":65},"Margaret A Niznikiewicz, Ph.D.","6176534627","margaret_niznikiewicz@hms.harvard.edu",[67],{"facility":68,"status":69,"city":70,"state":71,"zip":34,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Shanghai Mental Health Center","RECRUITING","Shanghai","Shanghai Municipality","China","CN",{"type":75,"coordinates":76},"Point",[77,78],121.45806,31.22222,{"lat":78,"lon":77},[81],{"name":82,"role":59,"phone":34,"phoneExt":34,"email":34},"Jijun Wang, MD",{"type":56,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"William Stone","Associate Professor of Psychology in the Department of Psychiatry",[87,89,91,93,95,98],{"name":88,"class":6},"Shanghai Jiao Tong University School of Medicine",{"name":90,"class":6},"Florida A&M University",{"name":92,"class":6},"Brigham and Women's Hospital",{"name":94,"class":6},"Massachusetts General Hospital",{"name":96,"class":97},"VA Boston Healthcare System","FED",{"name":99,"class":100},"National Institute of Mental Health (NIMH)","NIH","100557786","mechanisms-of-response-to-therapeutic-intervention-in-clinical-high-risk-chr-for-psychosis-100557786",false,"NCT06542640","Mechanisms of Response to Therapeutic Intervention in Clinical High Risk (CHR) for Psychosis","Identifying Mechanisms of Response to Therapeutic Intervention in Clinical High Risk (CHR) for Psychosis: a Bridge to Treatment","Inclusion Criteria:\n\nClinical High Risk (CHR):\n\n1. Male or female between 15 and 35 years old.\n2. Can understand and sign an informed consent (or assent for minors) document.\n3. Must meet the substance use criteria:\n\n   1. No Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) Alcohol or Drug Dependence in the past 3 months;\n   2. No use on the day of assessment, clearly not intoxicated or hung-over.\n4. Must meet diagnostic criteria for a prodromal syndrome. If under the age of 19 and meet diagnostic criteria for Schizotypal Personality Disorder or meet the diagnostic criteria called the Criteria for Prodromal Syndromes (COPS), which are operationalized as follows (a-c below):\n\n   1. Genetic Risk and Deterioration Syndrome (GRDS): First degree biological relative with psychosis or subject with Schizotypal Personality Disorder and a 30% drop in Global Assessment of Functioning (GAF) score compared to one year ago, sustained over the past month.\n   2. Attenuated Positive Symptoms Syndrome (APSS): Severity rating of moderate (rating of 3), moderately severe (4) or severe but not psychotic (5) on any one of the five Symptoms of Psychotic Disorders (SOPS) positive symptoms; symptom occurs at or above moderate severity level at an average frequency of at least once per week in the past month; symptom must have begun in the past year or currently rates at least one scale point higher than rated 12 months previously.\n   3. Brief Intermittent Psychotic Syndrome (BIPS): Severity rating of psychotic intensity (6) on any of the 5 SOPS positive symptoms; symptom is present at least several minutes per day at a frequency of at least once per month; symptom(s) must have reached a psychotic intensity in the past 3 months; symptom is not seriously disorganizing or dangerous; symptom(s) do not last for more than 1 hour\u002Fday at an average frequency of 4 days\u002Fweek over 1 month.\n5. . Participant may be remitted from the CHR syndrome or may have converted to a full psychotic disorder since study entry and either is acceptable - they remain eligible to participate in follow-up procedures.\n\nExclusion Criteria:\n\n1. Meet criteria for current or lifetime Axis I psychotic disorder, including affective psychoses and psychosis Not Otherwise Specified (NOS) at the baseline assessment\n2. Impaired intellectual functioning (i.e., Intelligence Quotient (IQ)\\\u003C70) at baseline.\n3. Past history of or current clinically significant central nervous system disorder that may contribute to prodromal symptoms or confound their assessment.\n4. Traumatic Brain Injury that is rated as 7 or above on the Traumatic Brain Injury screening instrument (signifying a significant brain injury with persistent sequelae) or current concussion that interferes with any assessment measures.\n5. Diagnostic prodromal symptoms that are clearly caused by one or more other psychiatric disorders, including substance use disorders, in the judgment of the evaluating clinician. Other non-psychotic Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) disorders will not be exclusionary (e.g., substance abuse disorder, major depression, anxiety disorders, personality disorders), as long as the disorder does not account for the diagnosis of prodromal symptoms.\n\nHealthy Controls (HC):\n\n1. Must meet subject inclusion criteria 1-2 and exclusion criteria 1-5. Must not meet criteria for any prodromal syndrome, any current or past psychotic disorder or Cluster A personality disorder diagnosis and must not be receiving any current treatment with psychotropic medication at the baseline assessment.\n2. Must not have a family history (in first-degree relatives) of schizophrenia, schizoaffective disorder, schizotypal personality disorder, or any other disorder involving psychotic symptoms.",true,"ALL","15 Years","35 Years",{"count":113,"type":114},300,"ESTIMATED","INTERVENTIONAL",[117],"NA","This study, \"Psychobiological Follow-up Study of Transition from Prodrome to Early Psychosis\", will be conducted in collaboration with the Shanghai Mental Health Center (SMHC) and several data processing sites in the United States. The current study builds on findings from the investigator's previous work that identified several biomarkers in participants at clinical high risk (CHR) for psychosis that may be related to clinical outcomes such as the development of psychosis. This study responds to the critical need to understand links between biomarkers (could be clinical, cognitive, biological or other abnormalities) and later clinical outcomes.\n\nParticipants will receive either one of two real interventions or one of two sham (a procedure that looks like the real treatment but is not) interventions, involving either: 1. repetitive transcranial magnetic stimulation (rTMS)1; or 2. mindfulness-based real time fMRI neurofeedback (mb-rt-fMRI-NFB). Both procedures will measure brain capacity for change in CHR individuals, thus paving the way forward for future therapeutic interventions.\n\nThe main hypotheses to be addressed by this study are:\n\n1. \\- Following real interventions, novel biomarkers will be more effective predictors of clinical outcome than standard biomarkers in participants at CHR for psychosis\n2. \\- Following real interventions, novel biomarkers will be more effective predictors of clinical outcomes in participants who received the real intervention than in participants who received sham treatments\n3. \\- The novel interventions will reduce biomarker abnormalities in individuals with CHR relative to their own baselines and relative to healthy controls (HC)\n4. \\- The sham interventions will will not reduce biomarker abnormalities in individuals with CHR relative to their own baselines or relative to HC",[120,121],"Psychosis; Schizophrenia-Like","Healthy Controls",[123,124,125,126,127,128,129,130,131],"real-time fMRI neurofeedback (rt-fMRI-NFB)","mindfulness-based (mb)","mb rt-fMRI-NFB (mb-rt-fMRI-NFB)","repet. transcran mag stim (rTMS)","neuropsycho (NP)","diffusion tensor imaging (DTI)","clinical high risk (CHR)","healthy control (HC)","MATRICS Consenus Cog Batt (MCCB)","2025-04-16",{"date":134,"type":135},"2025-04-20","ACTUAL",{"date":137,"type":135},"2024-01-01",{"date":139,"type":114},"2027-06-30",{"name":5,"class":6},1]