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

ConditionsPsychosisSchizophrenia Disorder
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Accelerated iTBS

    Device

    * 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

    Device

    * 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

    Device

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

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Accelerated iTBSExperimental treatment 1 intervention
Group B: High-Frequency rTMSActive comparator 1 intervention
Group C: Sham rTMSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)

Assessment of cognitive function in multiple domains

Time frame
Baseline, 2 weeks, 4 weeks, 12 weeks

Secondary outcomes

1

Change in Social Cognition Rating Tool in Indian Setting (SOCRATIS)

Time frame
Baseline, 2 weeks, 4 weeks, 12 weeks
2

Change in Positive and Negative Syndrome Scale (PANSS)

Time frame
Baseline, 2 weeks, 4 weeks, 12 weeks
3

Change in cerebral metabolic rate (FDG-PET)

Time frame
Baseline, 4 weeks, 12 weeks
4

Change in biomarkers (Neurogranin and NFLP levels)

Time frame
Baseline, 4 weeks, 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

All India Institute of Medical Sciences, Bhubaneswar

Lead sponsor

Indian Council of Medical Research

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: