PsychosisDB RCTNCT07445620
Comparison of Accelerated Intermittent Theta Burst Stimulation vs High Frequency Transcranial Magnetic Stimulation (Hf-rTMS) on Cognitivesymptoms in Treatment-resistant Schizophrenia
A study testing Accelerated iTBS and High-Frequency rTMS in people with Psychosis and Schizophrenia Disorder, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Psychosis, Schizophrenia Disorder
- What is being tested?
- Accelerated iTBS and High-Frequency rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- 15 Sep 2026to 14 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
AIIMS Bhubaneswar
Bhubaneswar, Odisha, 751019
Exucutive Director, MD, +91 0674-2476083, director@aiimsbhubaneswar.edu.in
About this study
Official title: Comparison of Accelerated Intermittent Theta Burst Stimulation vs High Frequency Transcranial Magnetic Stimulation (Hf-rTMS) on Cognitivesymptoms in Treatment-resistant Schizophrenia: DB-RCT
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:
- 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:
- 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
- Conditions
- Psychosis, Schizophrenia Disorder
- Being tested
- Accelerated iTBS, High-Frequency rTMS, Sham rTMS
- Keywords
- rTMS, Cognitive deficit
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated iTBSDevice
- 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 rTMSDevice
- 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 rTMSDevice
- Participants will receive sham stimulation using identical-appearing sham coil
- Same session schedule and positioning as active groups but without therapeutic magnetic field
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Device: Sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)
Assessment of cognitive function in multiple domains
Measured: Baseline, 2 weeks, 4 weeks, 12 weeks
Secondary outcomes (4)
Change in Social Cognition Rating Tool in Indian Setting (SOCRATIS)
Measured: Baseline, 2 weeks, 4 weeks, 12 weeks
Change in Positive and Negative Syndrome Scale (PANSS)
Measured: Baseline, 2 weeks, 4 weeks, 12 weeks
Change in cerebral metabolic rate (FDG-PET)
Measured: Baseline, 4 weeks, 12 weeks
Change in biomarkers (Neurogranin and NFLP levels)
Measured: Baseline, 4 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start15 Sep 2026 (estimated)
- Primary completion14 Feb 2029 (estimated)
- Study completion14 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Council of Medical Research
- Responsible party
- Principal investigator, Dr. Debadatta Mohapatra, All India Institute of Medical Sciences, Bhubaneswar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445620
- Sponsor's protocol ID
- T/EMF/Psych/2023-24/282
- Acronym
- DB RCT
- Status last verified
- Aug 2026
- First submitted
- 23 Feb 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Accelerated Intermittent Theta Burst Stimulation vs High Frequency Transcranial Magnetic Stimulation (Hf-rTMS) on Cognitivesymptoms in Treatment-resistant Schizophrenia: DB-RCT
- ClinicalTrials.gov ID
- NCT07445620
- Acronym / sponsor ID
- DB RCT / T/EMF/Psych/2023-24/282
- Conditions
- Psychosis, Schizophrenia Disorder
- Keywords
- rTMS, Cognitive deficit
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Collaborators
- Indian Council of Medical Research
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 14 Feb 2029 (estimated)
- Study completion
- 14 Dec 2029 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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:
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Accelerated iTBS | Experimental | Device: 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 |
| High-Frequency rTMS | Active comparator | Device: 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 rTMS | Sham comparator | Device: 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
| 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 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 |
Primary outcome
Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)
Time frame: Baseline, 2 weeks, 4 weeks, 12 weeks
Assessment of cognitive function in multiple domains
4 secondary outcomes
Change in Social Cognition Rating Tool in Indian Setting (SOCRATIS)
Time frame: Baseline, 2 weeks, 4 weeks, 12 weeks
Change in Positive and Negative Syndrome Scale (PANSS)
Time frame: Baseline, 2 weeks, 4 weeks, 12 weeks
Change in cerebral metabolic rate (FDG-PET)
Time frame: Baseline, 4 weeks, 12 weeks
Change in biomarkers (Neurogranin and NFLP levels)
Time frame: Baseline, 4 weeks, 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated iTBS and High-Frequency rTMS in people with Psychosis and Schizophrenia Disorder, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Debadatta Mohapatra, MD (+91 9437658251, psych_debadatta@aiimsbhubaneswar.edu.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Cognitive Assessment Tool for Schizophrenia (B-CATS) (time frame: Baseline, 2 weeks, 4 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.