SCHIZOPHRENIA 1 (Disorder)ButtomVPNCT07469384
Non-invasive Brain Stimulation Using Tdcs of the Third (of Many) Visual Pathways
A study testing transcranial direct current stimulation in people with SCHIZOPHRENIA 1 (Disorder) and Schizo Affective Disorder, run by Nathan Kline Institute for Psychiatric Research at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- SCHIZOPHRENIA 1 (Disorder), Schizo Affective Disorder
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2026to Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subject, age 18-55
- Competent and willing to sign informed consent
- No more than moderately ill
- SCID DSM-5 diagnosis of Sz/SzAff
- WAIS IQ >70
- Does not meet current criteria for DSM-5 defined substance abuse or dependence or have a history of diagnosis within past 6 months
- On medication within clinically approved range
- Does not meet criteria for another DSM-5 disorder other than those judged to be minor (e.g. simple phobia)
Who cannot join
- Significant neurological illness or history of significant head trauma
- Unstable physical illness or significant auditory/visual deficits that might interfer
- Contraindication to MRI (e.g. metal implants, claustrophobia, pregnancy)
- Contraindications to tDCS including metal implant, pacemaker, history of seizure, traumatic brain injury or stroke
- Significant risk for suicide
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nathan Kline Institute
Orangeburg, New York, 10962
Odeta Beggel, MA, 845-398-2897, odeta.beggel@nki.rfmh.org
Daniel C Javitt, MD, PhD
About this study
Official title: Sensory Contributions to Third Visual Pathway Dysfunction in Schizophrenia: Correlation and Causation
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.
Read the detailed description
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.
- Being tested
- transcranial direct current stimulation, Sham stimulation
- Keywords
- social cognition, fMRI, event-related potentials, motion detection, face emotion recognition, transcranial direct current stimulation
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
tDCS will be applied over cortical region MT+
Sham stimulationDevice
Ramp up/ramp down to simulate scalp sensation associated with tDCS. No sustained current flow
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | Personalized, high-definition tDCS applied to area MT+ Receives: Device: transcranial direct current stimulation |
| Sham tDCS | Sham comparator | Sham tDCS applied over area MT+, using ramp up/ramp down to simulate active treatment Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Simultaneously with the administration of the active or sham tDCS intervention during study day 3
Secondary outcomes (6)
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
Measured: Simultaneously with the administration of the active or sham tDCS intervention during study day 10
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Simultaneously with the administration of the active or sham tDCS intervention during study day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Feb 2026
- Primary completionApr 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SCHIZOPHRENIA 1 (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nathan Kline Institute for Psychiatric Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Columbia University, Research Foundation for Mental Hygiene, Inc.
- Responsible party
- Principal investigator, Daniel C. Javitt, MD, PhD, Nathan Kline Institute for Psychiatric Research
- Investigators
- Daniel C Javitt, MD, PhD, Principal investigator, Nathan Kline InstituteAntigona Martinez, PhD, Principal investigator, Nathan Kline Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469384
- Sponsor's protocol ID
- NKI2025-28
- Other IDs
- R01MH138939
- Acronym
- ButtomVP
- Status last verified
- Mar 2026
- First submitted
- 20 Feb 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data will be shared through the NIMH Data Archive (NDA) using standard procedures
Publications
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.
PubMed 35237135
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Contributions to Third Visual Pathway Dysfunction in Schizophrenia: Correlation and Causation
- ClinicalTrials.gov ID
- NCT07469384
- Acronym / sponsor ID
- ButtomVP / NKI2025-28
- Keywords
- social cognition, fMRI, event-related potentials, motion detection, face emotion recognition, transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nathan Kline Institute for Psychiatric ResearchUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Columbia University, Research Foundation for Mental Hygiene, Inc.
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: transcranial direct current stimulationPersonalized, high-definition tDCS applied to area MT+ |
| Sham tDCS | Sham comparator | Device: Sham stimulationSham tDCS applied over area MT+, using ramp up/ramp down to simulate active treatment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female subject, age 18-55
- Competent and willing to sign informed consent
- No more than moderately ill
- SCID DSM-5 diagnosis of Sz/SzAff
- WAIS IQ >70
Key exclusion criteria (7 listed)
- Significant neurological illness or history of significant head trauma
- Unstable physical illness or significant auditory/visual deficits that might interfer
- Contraindication to MRI (e.g. metal implants, claustrophobia, pregnancy)
- Contraindications to tDCS including metal implant, pacemaker, history of seizure, traumatic brain injury or stroke
- Significant risk for suicide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulationtDCS will be applied over cortical region MT+ | Device | Active tDCS |
| Sham stimulationRamp up/ramp down to simulate scalp sensation associated with tDCS. No sustained current flow | Device | Sham tDCS |
Primary outcome
MT+ activation as determined using fMRI
Time frame: Simultaneously with the administration of the active or sham tDCS intervention during study day 10
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
MT+ activation as determined using event-related potentials (ERP)
Time frame: Simultaneously with the administration of the active or sham tDCS intervention during study day 3
Amplitude of the ERP response to random dot kinematogram (RDK) stimulation, measured in microvolts
6 secondary outcomes
Activation of the third visual pathway (regions pSTS/mSTS) during a dynamic face emotion recognition (FER) task, as measured using fMRI
Time frame: Simultaneously with the administration of the active or sham tDCS intervention during study day 10
Fractional occupancy (FO) of the TVP CAP state
Time frame: 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
Time frame: Simultaneously with the administration of the active or sham tDCS intervention during study day 3
Motion discrimination threshold
Time frame: Simultaneously with the administration of the active or sham tDCS intervention during study day 3
Face emotion recognition (FER) accuracy
Time frame: Simultaneously with the administration of the active or sham tDCS intervention during study day 3
Understanding mental states (UMS) accuracy
Time frame: Simultaneously with the administration of the active or sham tDCS intervention during study day 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Results publication: PubMed 35237135Martinez 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.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared through the NIMH Data Archive (NDA) using standard procedures
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel C Javitt, MD, PhD principal investigator
Nathan Kline Institute
Antigona Martinez, PhD principal investigator
Nathan Kline Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with SCHIZOPHRENIA 1 (Disorder) and Schizo Affective Disorder, run by Nathan Kline Institute for Psychiatric Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Odeta Beggel, MA (845-398-2897, odeta.beggel@nki.rfmh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MT+ activation as determined using fMRI (time frame: Simultaneously with the administration of the active or sham tDCS intervention during study day 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07469384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.