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

Condition(s) studied

Investigational drug(s) / intervention(s)

Accelerated iTBS: * Participants will receive aITBS using 100X transcranial magnetic stimulator with 70 mm active cooled figure-of-eight coil * Parameters: 3 pulses at 50 Hz bursts, 2 sec on/10 sec off, 3 minutes per session * Dosage: 1800 pulses per day (3 rounds separated by 15 min), 5 days/week for 4 weeks

High-Frequency rTMS: * Participants will receive HF-rTMS using 100X transcranial magnetic stimulator with 70 mm active cooled figure-of-eight coil * Parameters: 20 Hz pulses, 20 minutes, 4 sec per second, intertrain interval 20 sec, 110% RMT * Dosage: 5 sessions per week for 4 weeks

Sham rTMS: * Participants will receive sham stimulation using identical-appearing sham coil * Same session schedule and positioning as active groups but without therapeutic magnetic field

Study 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.

Eligibility

Primary outcome measure(s)

• Brief Cognitive Assessment Tool for Schizophrenia (B-CATS) — Baseline, 2 weeks, 4 weeks, 12 weeks
  Assessment of cognitive function in multiple domains

Trial sites (1)