Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07445620
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:
NCT07445620
Study Brief:
Protocol Section:
NCT07445620