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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D003072', 'term': 'Cognition Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-12-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-02-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 12 weeks', 'description': 'Assessment of cognitive function in multiple domains'}], 'secondaryOutcomes': [{'measure': 'Change in Social Cognition Rating Tool in Indian Setting (SOCRATIS)', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 12 weeks'}, {'measure': 'Change in Positive and Negative Syndrome Scale (PANSS)', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 12 weeks'}, {'measure': 'Change in cerebral metabolic rate (FDG-PET)', 'timeFrame': 'Baseline, 4 weeks, 12 weeks'}, {'measure': 'Change in biomarkers (Neurogranin and NFLP levels)', 'timeFrame': 'Baseline, 4 weeks, 12 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rTMS', 'Cognitive deficit'], 'conditions': ['Psychosis', 'Schizophrenia Disorder']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nStudy 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.\n\nIntervention Details:\n\n* 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)\n* 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)\n* Group 3 (Sham): Sham stimulation using identical-appearing coil, same schedule as active groups\n* 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.\n\nPrimary Outcome: Change in Brief Cognitive Assessment Tool for Schizophrenia (B-CATS) score from baseline to 2 weeks, 4 weeks, and 12 weeks.\n\nSecondary Outcomes:\n\n* Change in Social Cognition Rating Tool in Indian Setting (SOCRATIS) score\n* Change in Positive and Negative Syndrome Scale (PANSS) score\n* Change in cerebral metabolic rate measured by FDG-PET\n* 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.\n\nStudy Details Study Type Interventional (Clinical Trial) Study Phase Phase 2/Phase 3 Study Design\n\n* Allocation: Randomized\n* Intervention Model: Parallel Assignment (3 arms)\n* Masking: Double Blind (Participant, Outcomes Assessor)\n* Primary Purpose: Treatment Condition Treatment-Resistant Schizophrenia Intervention\n* Device: Accelerated Intermittent Theta Burst Stimulation (aITBS)\n* Device: High-Frequency Repetitive Transcranial Magnetic Stimulation (HF-rTMS)\n* Device: Sham Transcranial Magnetic Stimulation Arms and Interventions Experimental: Accelerated iTBS\n* Participants will receive aITBS using 100X transcranial magnetic stimulator with 70 mm active cooled figure-of-eight coil\n* Parameters: 3 pulses at 50 Hz bursts, 2 sec on/10 sec off, 3 minutes per session\n* Dosage: 1800 pulses per day (3 rounds separated by 15 min), 5 days/week for 4 weeks Active Comparator: High-Frequency rTMS\n* Participants will receive HF-rTMS using 100X transcranial magnetic stimulator with 70 mm active cooled figure-of-eight coil\n* Parameters: 20 Hz pulses, 20 minutes, 4 sec per second, intertrain interval 20 sec, 110% RMT\n* Dosage: 5 sessions per week for 4 weeks Sham Comparator: Sham rTMS\n* Participants will receive sham stimulation using identical-appearing sham coil\n* Same session schedule and positioning as active groups but without therapeutic magnetic field Outcome Measures\n\nPrimary Outcome Measures:\n\n1\\. Change in Brief Cognitive Assessment Tool for Schizophrenia (B-CATS) Score\n\n* Time Frame: Baseline, 2 weeks, 4 weeks, 12 weeks\n* Description: Assessment of cognitive function in multiple domains\n\nSecondary Outcome Measures:\n\n1\\. Change in Social Cognition Rating Tool in Indian Setting (SOCRATIS)\n\n* Time Frame: Baseline, 2 weeks, 4 weeks, 12 weeks 2. Change in Positive and Negative Syndrome Scale (PANSS)\n* Time Frame: Baseline, 2 weeks, 4 weeks, 12 weeks 3. Change in cerebral metabolic rate (FDG-PET)\n* Time Frame: Baseline, 4 weeks, 12 weeks 4. Change in biomarkers (Neurogranin and NFLP levels)\n* Time Frame: Baseline, 4 weeks, 12 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with treatment-resistant schizophrenia according to TRIIP Consensus criteria\n* Age: 18-60 years\n* Currently receiving clozapine treatment for at least 6 months\n* Attending psychiatry outpatient department at AIIMS Bhubaneswar\n\nExclusion Criteria:\n\n* Currently receiving or recently received ECT/rTMS/tDCS\n* Co-morbid psychiatric, major medical, or neurological disorders\n* History of withdrawal seizures, delirium tremens, or significant head injury\n* Presence of pacemaker or metal in any part of body (excluding mouth)\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT07445620', 'acronym': 'DB RCT', 'briefTitle': 'Comparison of Accelerated Intermittent Theta Burst Stimulation vs High Frequency Transcranial Magnetic Stimulation (Hf-rTMS) on Cognitivesymptoms in Treatment-resistant Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'All India Institute of Medical Sciences, Bhubaneswar'}, 'officialTitle': 'Comparison of Accelerated Intermittent Theta Burst Stimulation vs High Frequency Transcranial Magnetic Stimulation (Hf-rTMS) on Cognitivesymptoms in Treatment-resistant Schizophrenia: DB-RCT', 'orgStudyIdInfo': {'id': 'T/EMF/Psych/2023-24/282'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Accelerated iTBS', 'description': '* Participants will receive aITBS using 100X transcranial magnetic stimulator with 70 mm active cooled figure-of-eight coil\n* Parameters: 3 pulses at 50 Hz bursts, 2 sec on/10 sec off, 3 minutes per session\n* Dosage: 1800 pulses per day (3 rounds separated by 15 min), 5 days/week for 4 weeks', 'interventionNames': ['Device: Accelerated iTBS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High-Frequency rTMS', 'description': '* Participants will receive HF-rTMS using 100X transcranial magnetic stimulator with 70 mm active cooled figure-of-eight coil\n* Parameters: 20 Hz pulses, 20 minutes, 4 sec per second, intertrain interval 20 sec, 110% RMT\n* Dosage: 5 sessions per week for 4 weeks', 'interventionNames': ['Device: High-Frequency rTMS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham rTMS', 'description': '* Participants will receive sham stimulation using identical-appearing sham coil\n* Same session schedule and positioning as active groups but without therapeutic magnetic field', 'interventionNames': ['Device: Sham rTMS']}], 'interventions': [{'name': 'Accelerated iTBS', 'type': 'DEVICE', 'description': '* Participants will receive aITBS using 100X transcranial magnetic stimulator with 70 mm active cooled figure-of-eight coil\n* Parameters: 3 pulses at 50 Hz bursts, 2 sec on/10 sec off, 3 minutes per session\n* Dosage: 1800 pulses per day (3 rounds separated by 15 min), 5 days/week for 4 weeks', 'armGroupLabels': ['Accelerated iTBS']}, {'name': 'High-Frequency rTMS', 'type': 'DEVICE', 'description': '* Participants will receive HF-rTMS using 100X transcranial magnetic stimulator with 70 mm active cooled figure-of-eight coil\n* Parameters: 20 Hz pulses, 20 minutes, 4 sec per second, intertrain interval 20 sec, 110% RMT\n* Dosage: 5 sessions per week for 4 weeks', 'armGroupLabels': ['High-Frequency rTMS']}, {'name': 'Sham rTMS', 'type': 'DEVICE', 'description': '* Participants will receive sham stimulation using identical-appearing sham coil\n* Same session schedule and positioning as active groups but without therapeutic magnetic field', 'armGroupLabels': ['Sham rTMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '751019', 'city': 'Bhubaneswar', 'state': 'Odisha', 'country': 'India', 'contacts': [{'name': 'Exucutive Director, MD', 'role': 'CONTACT', 'email': 'director@aiimsbhubaneswar.edu.in', 'phone': '+91 0674-2476083'}], 'facility': 'AIIMS Bhubaneswar', 'geoPoint': {'lat': 20.27241, 'lon': 85.83385}}], 'centralContacts': [{'name': 'Debadatta Mohapatra, MD', 'role': 'CONTACT', 'email': 'psych_debadatta@aiimsbhubaneswar.edu.in', 'phone': '+91 9437658251'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'All India Institute of Medical Sciences, Bhubaneswar', 'class': 'OTHER'}, 'collaborators': [{'name': 'Indian Council of Medical Research', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Officer', 'investigatorFullName': 'Dr. Debadatta Mohapatra', 'investigatorAffiliation': 'All India Institute of Medical Sciences, Bhubaneswar'}}}}