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

NCT07469384 | Recruiting DMC FDA Device

• 2 other identifiers: NKI2025-28R01MH138939
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

SCHIZOPHRENIA 1 (Disorder); Schizo Affective Disorder

Keywords

social cognition; fMRI; event-related potentials; motion detection; face emotion recognition; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Activation of the third visual pathway (regions pSTS/mSTS) during a dynamic face emotion recognition (FER) task, as measured using fMRI

  Simultaneously with the administration of the active or sham tDCS intervention during study day 10

• Fractional occupancy (FO) of the TVP CAP state

  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

  Simultaneously with the administration of the active or sham tDCS intervention during study day 3

• Motion discrimination threshold

  Simultaneously with the administration of the active or sham tDCS intervention during study day 3

• Face emotion recognition (FER) accuracy

  Simultaneously with the administration of the active or sham tDCS intervention during study day 3

Study Arms (2)

Active tDCS

EXPERIMENTAL

Personalized, high-definition tDCS applied to area MT+

Device: transcranial direct current stimulation

Sham tDCS

SHAM COMPARATOR

Sham tDCS applied over area MT+, using ramp up/ramp down to simulate active treatment

Device: Sham stimulation

Interventions

Sham stimulation DEVICE

Ramp up/ramp down to simulate scalp sensation associated with tDCS. No sustained current flow

Sham tDCS

transcranial direct current stimulation DEVICE

tDCS will be applied over cortical region MT+

Active tDCS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nathan Kline Institute for Psychiatric Research: lead
• National Institute of Mental Health (NIMH): collaborator
• Columbia University: collaborator
• Research Foundation for Mental Hygiene, Inc.: collaborator

Study Sites (1)

Nathan Kline Institute

Orangeburg, New York, 10962, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 35237135 RESULT

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Daniel C Javitt, MD, PhD

  Nathan Kline Institute

  PRINCIPAL INVESTIGATOR

• Antigona Martinez, PhD

  Nathan Kline Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Odeta Beggel, MA

CONTACT

845-398-2897; odeta.beggel@nki.rfmh.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Schizophrenia Research

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: March 13, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Time frame for sharing will be in accordance with the standard operating procedures of the NIMH data archive (NDA)
• Access Criteria: Access criteria will be in accordance with the standard operating procedures of the NIMH data archive (NDA)

Locations

US (1)