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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAll India Institute of Medical Sciences, Bhubaneswar

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

90 Participants
are divided into 3 treatment groups

Sponsors and collaborators

All India Institute of Medical Sciences, Bhubaneswar

Lead sponsor

Indian Council of Medical Research

Collaborator