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RecruitingNCT06118268iSCIPUpdated Oct 1, 2026

iTBS to Enhance Social Cognition in People With Psychosis

An interventional study of iTBS (Active) and iTBS (Sham) in Schizophrenia, Schizo Affective Disorder and Schizophreniform Disorders, sponsored by Northwell Health. Recruiting at 1 site in United States. Open to participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Northwell Health · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Apr 2023, registered Oct 2023).
  • Started Apr 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 39 Years
Sex
All
01

Study summary

The goal of this clinical trial is to examine if iTBS applied to the DMPFC improves social cognitive performance compared to sham stimulation in people diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychotic disorder not otherwise specified. The main objectives of this trial are:

  • Compare changes in social cognitive performance between the active vs. sham treatment groups
  • Compare changes in social cognitive network functional connectivity between the active vs. sham treatment groups

Each participant will receive iTBS (active or sham) five days per week for four consecutive weeks. Functional magnetic resonance imaging (fMRI) scans, clinical assessments, and cognitive tests will be performed at pre-treatment, post-treatment, and 6 months after the completion of treatment.

02

Conditions studied

  • Schizophrenia
  • Schizo Affective Disorder
  • Schizophreniform Disorders
  • Psychosis Nos/Other

Keywords

  • TMS
  • iTBS
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's planned enrollment of 100 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Northwell Health is the lead sponsor of 463 studies on the registry; 109 are open to participants now.

Of its 40 completed or terminated interventional studies of FDA-regulated products, 20 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 18-39 years.
  2. DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychotic disorder not otherwise specified (documented by SCID-5).
  3. Prescription of antipsychotic medication for at least 60 days and constant dose for 30 days prior to study entry (either first- or second-generation antipsychotics permitted).
  4. Able to participate in the informed consent process and provide voluntary informed consent.

Exclusion criteria

Exclusion Criteria:

  1. A history of a DSM-5 substance use disorder (other than cannabis, caffeine, or tobacco) within the past six months; or a positive baseline urine drug screen. Only participants meeting for moderate to severe cannabis use disorder will be excluded.
  2. Type 1 diabetes mellitus (i.e., insulin-dependent diabetes mellitus with onset \< 35 years of age and/or diabetes mellitus that has been complicated by a prior documented episode of ketoacidosis)
  3. Acute or unstable medical illness (e.g., delirium, cancer, uncontrolled diabetes, decompensated cardiac, hepatic, renal or pulmonary disease, stroke, or myocardial infarction), whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol
  4. Neurological disease associated with extrapyramidal signs and symptoms (e.g., Parkinson's disease); epilepsy, if the person has had one or more grand mal seizures in the past 18 months; history or physical signs of stroke; any diagnosis of a Central Nervous System (CNS) disorder
  5. Requires a benzodiazepine with a dose equivalent to lorazepam 2 mg/day or higher due to the potential of these medications to limit the efficacy of iTBS
  6. Suspected DSM-5 intellectual disability based upon clinical interview and psychosocial history
  7. Prior Psychosurgery
  8. Presence of MRI contraindications (e.g., pacemakers)
  9. Pregnancy
  10. TMS treatment in the past three months
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Active iTBS

    Device: iTBS (Active)

  • Sham comparator
    Sham iTBS

    Device: iTBS (Sham)

Interventions

  • DeviceiTBS (Active)

    The present study is a double-blind, randomized clinical trial that will examine if iTBS applied to DMPFC improves social cognitive performance compared to sham stimulation DMPFC-iTBS will be administered using the MagPro R30 stimulator equipped with a Cool-B70 coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark), positioned under MRI guidance using the Visor 2.0 system (Advanced Neuro Technologies Enschede, Netherlands).

  • DeviceiTBS (Sham)

    DMPFC-iTBS will be administered using the MagPro R30 stimulator equipped with a Cool-B70 coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark), positioned under MRI guidance using the Visor 2.0 system (Advanced Neuro Technologies Enschede, Netherlands).

06

What researchers measure

Primary outcomes

  1. Change in social cognitive performance

    Measured using the emotion recognition (ER-40) task

    Time frame: From baseline to 4 weeks

  2. Change in social cognitive performance

    Measured using the reading the mind in the eyes (RMET) task

    Time frame: From baseline to 4 weeks

  3. Change in social cognitive performance

    Measured using the test of the awareness of social inference-revised (TASIT-R)

    Time frame: From baseline to 4 weeks

Secondary outcomes

  1. Change in social cognitive network functional connectivity

    Measured using the empathic accuracy fMRI task

    Time frame: From baseline to 4 weeks

07

Study locations

1 of 1 sites recruiting
  • Zucker Hillside Hospital
    Glen Oaks, New York 11004, United States
    Recruiting
08

References and documents

Publications

  • Oliver LD, Blumberger DM, Deng ZD, Hawco C, Dickie EW, Gallucci J, Jeyachandra J, Mansour S, Hare SM, Gold JM, Foussias G, Argyelan M, Daskalakis ZJ, Buchanan RW, Malhotra AK, Voineskos AN. Effects of personalized transcranial magnetic stimulation on social cognitive network functional connectivity in schizophrenia spectrum disorders: A double-blind, randomized, sham-controlled target engagement trial. Brain Stimul. 2026 Jul 29;19(5):103172. doi: 10.1016/j.brs.2026.103172. Online ahead of print. PubMed 42526755 ↗
09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date, oversight details, data sharing statement, references and index terms
1 update, last Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    Minor edits only
    + 5 other changes: verification date, oversight details, data sharing statement, references and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06118268
Lead sponsor
Northwell Health
Collaborators
Wellcome Trust, Centre for Addiction and Mental Health, University of Maryland, Baltimore
Responsible party
Anil K. Malhotra (Vice Chair Research, Zucker Hillside Hospital, Northwell Health) — Principal investigator
First posted
Nov 7, 2023
Start date
Apr 18, 2023
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Oct 1, 2026

Study contacts

Andrea Joanlanne
Contact
ajoanlanne@northwell.edu
718-470-8898

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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