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Not yet recruitingNCT07445620DB RCTUpdated Aug 10, 2026

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

An interventional study of Accelerated iTBS and High-Frequency rTMS in Psychosis and Schizophrenia Disorder, sponsored by All India Institute of Medical Sciences, Bhubaneswar. Not yet recruiting at 1 site in India. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by All India Institute of Medical Sciences, Bhubaneswar · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

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.

Read the detailed description

Objectives: This randomized controlled trial will compare the efficacy of aITBS, high-frequency rTMS, and sham TMS on cognition, social cognition, cerebral metabolism (via FDG PET), and inflammatory biomarkers (neurogranin and neurofilament light chain protein) in patients with TRS.

Study Design: This is a three-arm, parallel-group, randomized, sham-controlled, double-blind trial. Participants will be randomized 1:1:1 to receive either aITBS, high-frequency rTMS, or sham rTMS.

Intervention Details:

  • Group 1 (aITBS): 3 pulses at 50 Hz bursts, 2 seconds on/10 seconds off for 3 minutes (600 pulses per session), 3 rounds per day separated by 15 minutes (1800 pulses/day), 5 sessions/week for 4 weeks (20 sessions total)
  • Group 2 (HF-rTMS): 20 Hz pulses for 20 minutes, 4 seconds per second, intertrain interval 20 seconds, 110% resting motor threshold (RMT), 5 sessions/week for 4 weeks (20 sessions total)
  • Group 3 (Sham): Sham stimulation using identical-appearing coil, same schedule as active groups
  • Target: Dorsolateral prefrontal cortex for all groups Population: 90 patients (30 per group) with treatment-resistant schizophrenia according to TRIIP Consensus criteria, aged 18-60 years, receiving clozapine treatment for at least 6 months.

Primary Outcome: Change in Brief Cognitive Assessment Tool for Schizophrenia (B-CATS) score from baseline to 2 weeks, 4 weeks, and 12 weeks.

Secondary Outcomes:

  • Change in Social Cognition Rating Tool in Indian Setting (SOCRATIS) score
  • Change in Positive and Negative Syndrome Scale (PANSS) score
  • Change in cerebral metabolic rate measured by FDG-PET
  • Change in inflammatory biomarkers (neurogranin and NFLP levels) Assessment Timeline: Baseline, 2 weeks, 4 weeks (end of treatment), and 12 weeks (follow-up) Expected Outcome: If aITBS demonstrates superior improvement in cognitive deficits compared to high-frequency rTMS and sham, this study will provide evidence for a novel treatment protocol to enhance patient functionality and reduce healthcare burden in treatment-resistant schizophrenia.

Study Details Study Type Interventional (Clinical Trial) Study Phase Phase 2/Phase 3 Study Design

  • Allocation: Randomized
  • Intervention Model: Parallel Assignment (3 arms)
  • Masking: Double Blind (Participant, Outcomes Assessor)
  • Primary Purpose: Treatment Condition Treatment-Resistant Schizophrenia Intervention
  • Device: Accelerated Intermittent Theta Burst Stimulation (aITBS)
  • Device: High-Frequency Repetitive Transcranial Magnetic Stimulation (HF-rTMS)
  • Device: Sham Transcranial Magnetic Stimulation Arms and Interventions Experimental: 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 Active Comparator: 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 Comparator: 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 Outcome Measures

Primary Outcome Measures:

1. Change in Brief Cognitive Assessment Tool for Schizophrenia (B-CATS) Score

  • Time Frame: Baseline, 2 weeks, 4 weeks, 12 weeks
  • Description: Assessment of cognitive function in multiple domains

Secondary Outcome Measures:

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
02

Conditions studied

  • Psychosis
  • Schizophrenia Disorder

Keywords

  • rTMS
  • Cognitive deficit
03

In context

Psychotic Disorders

1,587 studies on the registry are indexed under Psychotic Disorders; 281 are open to participants now.

This study's planned enrollment of 90 is above the median of 65 across 1,320 interventional studies indexed under Psychotic Disorders.

Browse Psychotic Disorders studies →

Lead sponsor

All India Institute of Medical Sciences, Bhubaneswar is the lead sponsor of 59 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    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

    Device: Accelerated iTBS

  • Active comparator
    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

    Device: High-Frequency rTMS

  • Sham comparator
    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

    Device: Sham rTMS

Interventions

  • DeviceAccelerated 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

  • DeviceHigh-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

  • DeviceSham rTMS

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

06

What researchers measure

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Feb 2029, 28 months later.

Of 455 non-industry interventional studies with no phase under Psychotic Disorders, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 52. This study's planned 28 months is below that.

Counting every sponsor, half of 457 studies reached it within 34 months; a quarter within 19 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 23, 2026
First posted
Mar 3, 2026
StartEst.
Sep 15, 2026
Primary completionEst.
Feb 14, 2029
CompletionEst.
Dec 14, 2029
Last update
Aug 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07445620
Lead sponsor
All India Institute of Medical Sciences, Bhubaneswar
Collaborators
Indian Council of Medical Research
Responsible party
Dr. Debadatta Mohapatra (Associate Officer, All India Institute of Medical Sciences, Bhubaneswar) — Principal investigator
First posted
Mar 3, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Feb 14, 2029 (estimated)
Completion
Dec 14, 2029 (estimated)
Last update
Aug 10, 2026

Study contacts

Debadatta Mohapatra, MD
Contact
psych_debadatta@aiimsbhubaneswar.edu.in
+91 9437658251

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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