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

NCT07445620 | Not Yet Recruiting DMC

• 1 other identifier: T/EMF/Psych/2023-24/282
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychosis; Schizophrenia Disorder

Keywords

rTMS; Cognitive deficit

Outcome Measures

Primary Outcomes (1)

• Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)

  Assessment of cognitive function in multiple domains

  Baseline, 2 weeks, 4 weeks, 12 weeks

Secondary Outcomes (4)

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

  Baseline, 2 weeks, 4 weeks, 12 weeks

• Change in Positive and Negative Syndrome Scale (PANSS)

  Baseline, 2 weeks, 4 weeks, 12 weeks

• Change in cerebral metabolic rate (FDG-PET)

  Baseline, 4 weeks, 12 weeks

• Change in biomarkers (Neurogranin and NFLP levels)

  Baseline, 4 weeks, 12 weeks

Study Arms (3)

Accelerated iTBS

EXPERIMENTAL

* 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

Device: Accelerated iTBS

High-Frequency rTMS

ACTIVE COMPARATOR

* 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

Device: High-Frequency rTMS

Sham rTMS

SHAM COMPARATOR

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

Device: Sham rTMS

Interventions

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

Accelerated iTBS

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

High-Frequency rTMS

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

Sham rTMS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Pregnant or lactating women

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead
• Indian Council of Medical Research: collaborator

Study Sites (1)

AIIMS Bhubaneswar

Bhubaneswar, Odisha, 751019, India

Location

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia; Cognition Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurocognitive Disorders

Central Study Contacts

Debadatta Mohapatra, MD

CONTACT

+91 9437658251; psych_debadatta@aiimsbhubaneswar.edu.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Officer

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 3, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): February 14, 2029
• Study Completion (Estimated): December 14, 2029
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)