About this trial
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 criteria
Qualifiers
Diagnosed with treatment-resistant schizophrenia according to TRIIP Consensus criteria
Age: 18-60 years
Currently receiving clozapine treatment for at least 6 months
Attending psychiatry outpatient department at AIIMS Bhubaneswar
Disqualifiers
Currently receiving or recently received ECT/rTMS/tDCS
Co-morbid psychiatric, major medical, or neurological disorders
History of withdrawal seizures, delirium tremens, or significant head injury
Presence of pacemaker or metal in any part of body (excluding mouth)
Trial design
Treatments tested in this trial
- Accelerated iTBS
- High-Frequency rTMS
- Sham rTMS
Treatment groups
Sponsors and collaborators
All India Institute of Medical Sciences, Bhubaneswar
Lead sponsor
Indian Council of Medical Research
Collaborator