iTBS to Enhance Social Cognition in People With Psychosis

Part of paid clinical trials in Glen Oaks, New York.

Sponsor
Northwell Health
Study ID
NCT06118268
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • 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 Details

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.

Key Dates

Start date
Apr 18, 2023
Status verified
May 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active iTBS
  • Sham Comparator: Sham iTBS

Primary Outcome Measure

Change in social cognitive performance [ Time Frame: From baseline to 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Zucker Hillside HospitalGlen OaksNew York11004
Andrea Joanlanne
718-470-8898

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