Study of iTBS Treatment to Improve Social Thinking in Adults with Psychosis Aged 18 to 39
Led by Northwell Health · Updated on 2025-05-22
100
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating whether intermittent Theta Burst Stimulation iTBS applied to the dorsomedial prefrontal cortex DMPFC can improve social cognitive performance in people diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, or other psychotic disorders. This study aims to compare changes in social cognition and brain network connectivity between participants receiving active iTBS and those receiving sham stimulation. The trial is led by Northwell Health and involves adults aged 18 to 39 years.
Participants will receive either active or sham iTBS five days a week for four consecutive weeks. The iTBS is delivered using a MagPro R30 stimulator with a Cool-B70 coil and Qooler fluid-cooling device, positioned under MRI guidance with the Visor 2.0 system. The study is randomized and double-blind, meaning neither participants nor researchers know who receives active or sham treatment during the trial.
Throughout the study, participants will undergo functional MRI scans, clinical assessments, and cognitive testing before treatment, immediately after the four-week treatment period, and again six months later. Researchers will assess changes in social cognitive performance and brain network functional connectivity. The total participation period includes these evaluations to monitor lasting effects and safety.
CONDITIONS
Brief Title
iTBS to Enhance Social Cognition in People With Psychosis
Research Team
A
Andrea Joanlanne
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Active iTBS
Sham iTBS
What it is
A non-invasive brain stimulation technique called intermittent theta burst stimulation (iTBS) is applied to the dorsomedial prefrontal cortex. Sessions use MRI guidance to target the brain region and aim to modulate social cognitive function.
A sham (inactive) iTBS procedure mimics the appearance and sensation of active stimulation but does not deliver actual neuromodulation. It is intended to control for the placebo effect.
Role in trial
Tests whether active neuromodulation improves social cognitive performance in people with psychosis, compared to sham.
Serves as the placebo comparator arm to account for non-specific effects and participant expectations.
Primary use
Evaluated for its ability to enhance social cognition in adults with schizophrenia-spectrum or related psychotic disorders who are stable on antipsychotic medication.
Used as an inactive comparator to help determine the real effect of active iTBS on social cognition.
How it is given or performed
iTBS sessions are administered to the dorsomedial prefrontal cortex using the MagPro R30 stimulator and advanced positioning equipment for accurate targeting. Sessions are guided by MRI imaging.
Sham iTBS uses the same device setup and procedures, but no actual neuromodulation is applied.
Evidence status
Randomized trials are ongoing. One recent double-blind, sham-controlled study showed that personalized TMS targeting social cognitive networks could change brain connectivity, but a significant clinical advantage for social cognition has not yet been established.
Sham iTBS does not produce neuromodulation and serves as a placebo control. No improvement of social cognition is expected from sham procedures.
Important limitations
iTBS for social cognition remains investigational, with results limited by small study sizes and variable effects across studies. Key outcomes such as daily functioning and durability of effect are not yet clearly established.
Sham stimulation does not provide a therapeutic effect and may not account for all patient or rater expectations.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 18Years - 39Years
All Genders
Eligibility Criteria
You may qualify if you...
Age 18 to 39 years
Diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychotic disorder not otherwise specified (confirmed by SCID-5)
On antipsychotic medication for at least 60 days with a stable dose for 30 days before joining
Able to understand and provide informed consent voluntarily
You will not qualify if you...
History of substance use disorder (except cannabis, caffeine, or tobacco) within past six months or positive drug screen; moderate to severe cannabis use disorder excluded
Type 1 diabetes mellitus with early onset or history of ketoacidosis
Acute or unstable medical illness that may affect schizophrenia or increase treatment risk
Neurological diseases like Parkinson's, epilepsy with recent seizures, stroke, or other central nervous system disorders
Use of benzodiazepines at doses equivalent to lorazepam 2 mg/day or higher
Suspected intellectual disability based on clinical interview
Prior psychosurgery
MRI contraindications such as pacemakers
Pregnancy
Received TMS treatment in the past three months
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 4 weeks
Participants receive iTBS or sham stimulation applied to the DMPFC guided by MRI to assess effects on social cognition.
Multiple visits over 4 weeks for iTBS sessions
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
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.
Lindsay D Oliver, Daniel M Blumberger, Zhi-De Deng...