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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH138939 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Columbia University | OTHER |
| Research Foundation for Mental Hygiene, Inc. | OTHER |
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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).
Participants 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Experimental | Personalized, high-definition tDCS applied to area MT+ |
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| Sham tDCS | Sham Comparator | Sham tDCS applied over area MT+, using ramp up/ramp down to simulate active treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation | Device | tDCS will be applied over cortical region MT+ |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Activation of the third visual pathway (regions pSTS/mSTS) 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 | Simultaneously with the administration of the active or sham tDCS intervention during study day 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Odeta Beggel, MA | Contact | 845-398-2897 | odeta.beggel@nki.rfmh.org |
| Name | Affiliation | Role |
|---|---|---|
| Daniel C Javitt, MD, PhD | Nathan Kline Institute | Principal Investigator |
| Antigona Martinez, PhD | Nathan Kline Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nathan Kline Institute | Recruiting | Orangeburg | New York | 10962 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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/fnbeh.2021.787383. eCollection 2021. |
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Individual participant data will be shared through the NIMH Data Archive (NDA) using standard procedures
Time frame for sharing will be in accordance with the standard operating procedures of the NIMH data archive (NDA)
Access criteria will be in accordance with the standard operating procedures of the NIMH data archive (NDA)
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Sham stimulation | Device | Ramp up/ramp down to simulate scalp sensation associated with tDCS. No sustained current flow |
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| 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 | Simultaneously with the administration of the active or sham tDCS intervention during study day 10 |
| Activation of the third visual pathway (regions pSTS/mSTS) 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 | Simultaneously with the administration of the active or sham tDCS intervention during study day 3 |
| Motion discrimination threshold | % motion of the random dot kinetamatogram (RDK) stimuli needed for detection of motion, measured in percent | Simultaneously with the administration of the active or sham tDCS intervention during study day 3 |
| Face emotion recognition (FER) accuracy | % correct responses on the dynamic face emotion recognition task, measured as percent correct | Simultaneously with the administration of the active or sham tDCS intervention during study day 3 |
| Understanding mental states (UMS) accuracy | Percentage correct performance on the TASIT sarcasm task, measured as percent correct | Simultaneously with the administration of the active or sham tDCS intervention during study day 3 |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |