Non-invasive Brain Stimulation Using Tdcs of the Third (of Many) Visual Pathways (ButtomVP)

March 10, 2026 updated by: Daniel C. Javitt, MD, PhD, Nathan Kline Institute for Psychiatric Research

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • Orangeburg, New York, United States, 10962
        • Recruiting
        • Nathan Kline Institute
        • Contact:
        • Principal Investigator:
          • Daniel C Javitt, MD, PhD
        • Principal Investigator:
          • Antigona Martinez, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female subject, age 18-55
  2. Competent and willing to sign informed consent
  3. No more than moderately ill
  4. SCID DSM-5 diagnosis of Sz/SzAff
  5. WAIS IQ >70
  6. Does not meet current criteria for DSM-5 defined substance abuse or dependence or have a history of diagnosis within past 6 months
  7. On medication within clinically approved range
  8. Does not meet criteria for another DSM-5 disorder other than those judged to be minor (e.g. simple phobia)

Exclusion Criteria:

  1. Significant neurological illness or history of significant head trauma
  2. Unstable physical illness or significant auditory/visual deficits that might interfer
  3. Contraindication to MRI (e.g. metal implants, claustrophobia, pregnancy)
  4. Contraindications to tDCS including metal implant, pacemaker, history of seizure, traumatic brain injury or stroke
  5. Significant risk for suicide
  6. 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
  7. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active tDCS
Personalized, high-definition tDCS applied to area MT+
Device: transcranial direct current stimulation
tDCS will be applied over cortical region MT+
Sham Comparator: Sham tDCS
Sham tDCS applied over area MT+, using ramp up/ramp down to simulate active treatment
Device: Sham stimulation
Ramp up/ramp down to simulate scalp sensation associated with tDCS. No sustained current flow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Simultaneously with the administration of the active or sham tDCS intervention during study day 10
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
Simultaneously with the administration of the active or sham tDCS intervention during study day 3

Secondary Outcome Measures

Outcome Measure
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
Time Frame: Simultaneously with the administration of the active or sham tDCS intervention during study day 10
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
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
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
Time Frame: Simultaneously with the administration of the active or sham tDCS intervention during study day 3
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
Time Frame: Simultaneously with the administration of the active or sham tDCS intervention during study day 3
% 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
Time Frame: Simultaneously with the administration of the active or sham tDCS intervention during study day 3
% 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
Time Frame: Simultaneously with the administration of the active or sham tDCS intervention during study day 3
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nathan Kline Institute for Psychiatric Research

Collaborators

National Institute of Mental Health (NIMH)
Columbia University
Research Foundation for Mental Hygiene, Inc.

Investigators

  • Principal Investigator: Daniel C Javitt, MD, PhD, Nathan Kline Institute
  • Principal Investigator: Antigona Martinez, PhD, Nathan Kline Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

July 1, 2030

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKI2025-28
  • R01MH138939 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data will be shared through the NIMH Data Archive (NDA) using standard procedures

IPD Sharing Time Frame

Time frame for sharing will be in accordance with the standard operating procedures of the NIMH data archive (NDA)

IPD Sharing Access Criteria

Access criteria will be in accordance with the standard operating procedures of the NIMH data archive (NDA)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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