[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07469384":3,"trial-entities:NCT07469384":116,"trial-summary:NCT07469384":121},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":46,"secondary_outcomes":55,"sex":74,"minimum_age":75,"maximum_age":76,"healthy_volunteers":77,"eligibility_criteria":78,"std_ages":82,"locations":84,"central_contacts":105,"overall_officials":107,"references":110,"see_also_links":115},"NCT07469384","NKI2025-28","Non-invasive Brain Stimulation Using Tdcs of the Third (of Many) Visual Pathways","Sensory Contributions to Third Visual Pathway Dysfunction in Schizophrenia: Correlation and Causation","RECRUITING","2030-07","2026-03","2026-03-13","2026-02-01","Nathan Kline Institute for Psychiatric Research","OTHER",true,"This study investigates the ability of transcranial direct current stimulation (tDCS) applied over the motion processing area of the brain (area MT) to improve face emotion recognition (FER) ability. tDCS is a type of non-invasive brain stimulation in which low level currents are applied over the scalp to influence underlying brain function. In schizophrenia, impaired ability to detect facial motion has been shown to contribute to impaired FER, which, in turn, leads to difficulties in social cognition and poor social outcome. The study will use both fMRI and EEG to measure brain function while participants view moving dot and dynamic face stimuli. Analyses will compare changes in fMRI and EEG activity in individuals receiving active vs. sham stimulation.","The studey involves a randomized, parallel group comparison of personalized, MR-guided, cathodal HD-tDCS vs. sham targeting the middle temporal motion-sensitive region (HCP MMP1.0-atlas area MT+ complex) for the reversal of physiological impairments in Sz related to motion processing and social cognitive dysfunction. RDoC constructs to be tested include face emotion recognition (FER) and Understanding Mental State (UMS), which has also been termed Theory of Mind (ToM) or mentalizing. The overall goals of the study are to determine whether tDCS applied over MT+ can ameliorate 1) motion-processing deficits in Sz and 2) deficits in activation of other TVP regions. Key outcome measures include 1) activation of MT+, pSTS and mSTS regions to motion and dynamic FER stimuli and 2) fractional occupancy (FO) of the CAP state corresponding to the TVP structure. Behavioral outcomes will include scores on motion discrimination, FER to dynamic faces, and TASIT sarcasm (UMS).\n\nParticipants will include 120 individuals with Sz and 30 healthy controls (HC). Sz individuals will be evaluated both cross-sectionally and during blinded, randomized active (cathodal) or sham pHD-tDCS targeted to MTC. HC will be evaluated cross-sectionally only. All participants will first undergo baseline assessment (Visit 1) and baseline physiological assessments (Visit 2). Each Sz participant will then be assigned to blinded intervention with either active or sham tDCS and will participate in one ERP (Visit 3) and one fMRI session (Visit 4) involving up to 40-min stimulation each. The two tDCS sessions will be conducted at least 1 week apart and may occur in either order. For each participant, the same randomized treatment (active vs. sham tDCS) will be used in both the ERP and fMRI sessions (Visits 3 and 4). Behavior is obtained during the ERP session (Visit 3). Comparisons will focus on correlations among the fMRI, ERP and behavioral outcome measures within participants as well as the effects of active vs. sham tDCS across participants.",[19,20],"SCHIZOPHRENIA 1 (Disorder)","Schizo Affective Disorder",[22,23,24,25,26,27],"social cognition","fMRI","event-related potentials","motion detection","face emotion recognition","transcranial direct current stimulation","INTERVENTIONAL","TREATMENT",[31],"NA",{"count":33,"type":34},120,"ESTIMATED",[36,41],{"type":37,"name":27,"description":38,"armGroupLabels":39},"DEVICE","tDCS will be applied over cortical region MT+",[40],"Active tDCS",{"type":37,"name":42,"description":43,"armGroupLabels":44},"Sham stimulation","Ramp up\u002Framp down to simulate scalp sensation associated with tDCS. No sustained current flow",[45],"Sham tDCS",[47,51],{"measure":48,"description":49,"timeFrame":50},"MT+ activation as determined using fMRI","Magnitude of activation in area MT+ during random dot kinematogram (RDK) stimulation measured by the beta weight of the BOLD fMRI signal, expressed in units of percentage signal change","Simultaneously with the administration of the active or sham tDCS intervention during study day 10",{"measure":52,"description":53,"timeFrame":54},"MT+ activation as determined using event-related potentials (ERP)","Amplitude of the ERP response to random dot kinematogram (RDK) stimulation, measured in microvolts","Simultaneously with the administration of the active or sham tDCS intervention during study day 3",[56,59,62,65,68,71],{"measure":57,"description":58,"timeFrame":50},"Activation of the third visual pathway (regions pSTS\u002FmSTS) during a dynamic face emotion recognition (FER) task, as measured using fMRI","Magnitude of activation in areas pSTS and mSTS during the dynamic FER task as measured by the beta weight of the BOLD fMRI signal, expressed in units of percentage signal change",{"measure":60,"description":61,"timeFrame":50},"Fractional occupancy (FO) of the TVP CAP state","Fractional occupancy of the TVP CAP state during the NV-fMRI stimuli (Despicable me, Sherlock), as measured in percentage units",{"measure":63,"description":64,"timeFrame":54},"Activation of the third visual pathway (regions pSTS\u002FmSTS) during a dynamic face emotion recognition (FER) task, as measured using ERP","Amplitude of the ERP response to dynamic emotional face stimuli, measured in microvolts",{"measure":66,"description":67,"timeFrame":54},"Motion discrimination threshold","% motion of the random dot kinetamatogram (RDK) stimuli needed for detection of motion, measured in percent",{"measure":69,"description":70,"timeFrame":54},"Face emotion recognition (FER) accuracy","% correct responses on the dynamic face emotion recognition task, measured as percent correct",{"measure":72,"description":73,"timeFrame":54},"Understanding mental states (UMS) accuracy","Percentage correct performance on the TASIT sarcasm task, measured as percent correct","ALL","18 Years","55 Years",false,{"inclusion":79,"exclusion":80,"raw_text":81},[],[],"Inclusion Criteria:\n\n1. Male or female subject, age 18-55\n2. Competent and willing to sign informed consent\n3. No more than moderately ill\n4. SCID DSM-5 diagnosis of Sz\u002FSzAff\n5. WAIS IQ \\>70\n6. Does not meet current criteria for DSM-5 defined substance abuse or dependence or have a history of diagnosis within past 6 months\n7. On medication within clinically approved range\n8. Does not meet criteria for another DSM-5 disorder other than those judged to be minor (e.g. simple phobia)\n\nExclusion Criteria:\n\n1. Significant neurological illness or history of significant head trauma\n2. Unstable physical illness or significant auditory\u002Fvisual deficits that might interfer\n3. Contraindication to MRI (e.g. metal implants, claustrophobia, pregnancy)\n4. Contraindications to tDCS including metal implant, pacemaker, history of seizure, traumatic brain injury or stroke\n5. Significant risk for suicide\n6. Has a history of an illness, disease, condition injury, or disability which, in the opinion of the principal investigator, may interfere with the completion of all study requirements per protocol, impact the quality of the data, or the validity of the study results, including unstable physical illness, significant neurological illness, significant head trauma\n7. Moderate or greater DSM-5 current substance use disorder, defined based on the presence of 4 or more of 11 substance use criteria within the past 12 months. In addition, individuals for whom substance use leads to not being able to perform work, home or school activities",[83],"ADULT",[85],{"facility":86,"status":8,"city":87,"state":88,"zip":89,"country":90,"contacts":91,"geoPoint":102},"Nathan Kline Institute","Orangeburg","New York","10962","United States",[92,97,100],{"name":93,"role":94,"phone":95,"email":96},"Odeta Beggel, MA","CONTACT","845-398-2897","odeta.beggel@nki.rfmh.org",{"name":98,"role":99},"Daniel C Javitt, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":101,"role":99},"Antigona Martinez, PhD",{"lat":103,"lon":104},41.04649,-73.94958,[106],{"name":93,"role":94,"phone":95,"email":96},[108,109],{"name":98,"affiliation":86,"role":99},{"name":101,"affiliation":86,"role":99},[111],{"pmid":112,"type":113,"citation":114},"35237135","RESULT","Martinez A, Tobe RH, Gaspar PA, Malinsky D, Dias EC, Sehatpour P, Lakatos P, Patel GH, Bermudez DH, Silipo G, Javitt DC. Disease-Specific Contribution of Pulvinar Dysfunction to Impaired Emotion Recognition in Schizophrenia. Front Behav Neurosci. 2022 Feb 14;15:787383. doi: 10.3389\u002Ffnbeh.2021.787383. eCollection 2021.",[],{"nct_id":4,"conditions":117,"biomarkers":120},[118,119],"Schizoaffective Disorder","Schizophrenia",[],{"nct_id":4,"found":15,"summary":122,"prompt_version":132},{"design":123,"status":124,"heading":125,"summary":126,"follow_up":127,"word_count":128,"commitments":129,"compensation":130,"drugs_mentioned":131},"This is an interventional study with a randomized, parallel group design, comparing active tDCS to sham stimulation. It plans to enroll 120 participants with schizophrenia or schizoaffective disorder.","completed","Transcranial Direct Current Stimulation (tDCS) for Schizophrenia and Schizoaffective Disorder","This study is exploring if a non-invasive brain stimulation technique called transcranial direct current stimulation (tDCS) can help improve how people with schizophrenia or schizoaffective disorder recognize emotions from faces. tDCS involves applying a very low electrical current to the scalp over a specific brain area (MT+) that processes motion. Researchers believe that difficulties in seeing motion contribute to problems with recognizing emotions, which can affect social interactions. The study will compare tDCS to a sham (inactive) stimulation. Success will be measured by changes in brain activity (detected using fMRI and ERP) in the MT+ area and improvements in emotion recognition and understanding social cues. The study aims to enroll 120 participants with schizophrenia or schizoaffective disorder, aged 18-55, who are not severely ill and have an IQ above 70. The current recruitment status is unclear.","Brain activity will be measured during the intervention on study days 3 and 10. The record does not specify follow-up beyond this.",136,"Participants will undergo baseline assessments and physiological evaluations. They will receive either active or sham tDCS, with brain activity measured during these sessions on study days 3 and 10.","Not stated in the trial record.",[27],"v2"]