SchizophreniaiSCIPNCT06118268
iTBS to Enhance Social Cognition in People With Psychosis
A study testing iTBS (Active) in people with Schizophrenia and Schizo Affective Disorder, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Schizophrenia, Schizo Affective Disorder, Schizophreniform Disorders
- What is being tested?
- iTBS (Active)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2023to Apr 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-39 years.
- DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychotic disorder not otherwise specified (documented by SCID-5).
- 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).
- Able to participate in the informed consent process and provide voluntary informed consent.
Who cannot join
- 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.
- 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)
- 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
- 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
- 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
- Suspected DSM-5 intellectual disability based upon clinical interview and psychosocial history
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- Prior Psychosurgery
- Presence of MRI contraindications (e.g., pacemakers)
- Pregnancy
- TMS treatment in the past three months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Zucker Hillside Hospital
Glen Oaks, New York, 11004
Andrea Joanlanne, 718-470-8898, ajoanlanne@northwell.edu
About this study
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.
- Being tested
- iTBS (Active), iTBS (Sham)
- Keywords
- TMS, iTBS
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTBS (Active)Device
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).
iTBS (Sham)Device
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).
| Study group | Role | What they receive |
|---|---|---|
| Active iTBS | Active comparator | Not described Receives: Device: iTBS (Active) |
| Sham iTBS | Sham comparator | Not described Receives: Device: iTBS (Sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in social cognitive performance
Measured using the emotion recognition (ER-40) task
Measured: From baseline to 4 weeks
Change in social cognitive performance
Measured using the reading the mind in the eyes (RMET) task
Measured: From baseline to 4 weeks
Change in social cognitive performance
Measured using the test of the awareness of social inference-revised (TASIT-R)
Measured: From baseline to 4 weeks
Secondary outcomes (1)
Change in social cognitive network functional connectivity
Measured using the empathic accuracy fMRI task
Measured: From baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start30 Oct 2023
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, Centre for Addiction and Mental Health, University of Maryland, Baltimore
- Responsible party
- Principal investigator, Anil K. Malhotra, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118268
- Sponsor's protocol ID
- 23-0071
- Acronym
- iSCIP
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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