Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:06 AM
Study NCT ID:
NCT07445620
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Accelerated Intermittent Theta Burst Stimulation vs High Frequency Transcranial Magnetic Stimulation (Hf-rTMS) on Cognitivesymptoms in Treatment-resistant Schizophrenia
Sponsor:
All India Institute of Medical Sciences, Bhubaneswar
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DB RCT
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.
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: