Clinical Trial

Comparison of Accelerated Intermittent Theta Burst Stimulation vs High Frequency Transcranial Magnetic Stimulation (Hf-rTMS) on Cognitivesymptoms in Treatment-resistant Schizophrenia

Study acronym: DB RCT
Not Yet Recruiting
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Summary
This randomized, double-blind, sham-controlled trial compares three brain stimulation approaches-accelerated intermittent theta burst stimulation (aITBS), high-frequency repetitive transcranial magnetic stimulation (HF-rTMS), and sham stimulation-for treating cognitive deficits in treatment-resistant schizophrenia. Ninety patients receiving clozapine will be randomized 1:1:1 to receive 20 sessions over 4 weeks targeting the dorsolateral prefrontal cortex. The primary outcome is change in cognitive function measured by B-CATS score at 2, 4, and 12 weeks. Secondary outcomes include social cognition, symptom severity, brain metabolism (FDG-PET), and inflammatory biomarkers.
Trial Details
NCT Number NCT07445620
Lead Sponsor All India Institute of Medical Sciences, Bhubaneswar
Collaborators: Indian Council of Medical Research
Conditions Psychosis, Schizophrenia Disorder
Enrollment 90 participants
Start Date 2026-09-15
Primary Completion 2029-02-14 (estimated)
Study Completion 2029-12-14 (estimated)
Updated on ClinicalTrials.gov 2026-08-10