Recruiting

tDCS

Sponsor:

Nathan Kline Institute for Psychiatric Research

Code:

NCT07469384

Conditions

SCHIZOPHRENIA 1 (Disorder)

Schizo Affective Disorder

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

transcranial direct current stimulation

Sham stimulation

Study Details

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

Study ID

NCT07469384

Start date

Feb 1, 2026

Status verified date

Mar, 2026

Completion date

Jul, 2030

Anticipated

Primary completion date

Apr, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active tDCS

Personalized, high-definition tDCS applied to area MT+

sham comparator: Sham tDCS

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

Interventions

transcranial direct current stimulation

tDCS will be applied over cortical region MT+

Sham stimulation

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

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Nathan Kline Institute

Recruiting

Orangeburg, New York, United States, 10962

Contacts

Principal Investigator:

Daniel C Javitt, MD, PhD

More Information

Sponsor

Nathan Kline Institute for Psychiatric Research

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nathan Kline Institute for Psychiatric Research on 2026-03-13.