An interventional study of Sequential Dual-Site Accelerated Theta Burst Stimulation (SD-aTBS) and Sham Sequential Dual-Site Accelerated Theta Burst Stimulation in Schizophrenia / Schizoaffective Disorder, TMS and Cognitive, sponsored by Central South University. Not yet recruiting. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Central South University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if sequential dual-site accelerated theta burst stimulation (SD-aTBS) targeting the frontoparietal network and default mode network works to improve cognitive function in adults with schizophrenia. It will also learn about the safety of SD-aTBS. The main questions it aims to answer are:
Does SD-aTBS improve cognitive function in participants with schizophrenia? What are the neurobiological mechanisms (brain network and synaptic plasticity changes) underlying the effects of SD-aTBS? Researchers will compare real SD-aTBS to sham stimulation to see if SD-aTBS is effective and safe for treating cognitive impairment in schizophrenia.
Participants will:
Receive real SD-aTBS or sham stimulation for 10 consecutive working days Complete clinical symptom assessments, cognitive function tests, MRI scans, and EEG recordings at baseline, after treatment, and 1 month after treatment Undergo SV2A-PET scans at baseline and 1 month after treatment
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 60 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Central South University is the lead sponsor of 134 studies on the registry; 32 are open to participants now.
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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.
（4）Presence of significant cognitive impairment (overall deficit score of MCCB plus supplementary tests ≥ 0.5).
（5）The participant and their guardian agree to participate in the study and provide written .
Exclusion Criteria:
Withdrawal Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive active sequential dual-site accelerated theta burst stimulation (SD-aTBS) targeting the frontoparietal network and default mode network, delivered 5 times daily for 10 consecutive working days.
Device: Sequential Dual-Site Accelerated Theta Burst Stimulation (SD-aTBS)
Participants will receive sham sequential dual-site accelerated theta burst stimulation (SD-aTBS) targeting the frontoparietal network and default mode network, delivered 5 times daily for 10 consecutive working days.
Device: Sham Sequential Dual-Site Accelerated Theta Burst Stimulation
Sequential dual-site accelerated theta burst stimulation (SD-aTBS) delivers accelerated theta burst stimulation to two individually targeted brain regions - the frontoparietal network and the default mode network - in a sequential (site-by-site) manner, with stimulation delivered 5 times daily for 10 consecutive working days.
Sham sequential dual-site accelerated theta burst stimulation uses the same coil positioning and stimulation parameters as the active SD-aTBS but delivers no effective cortical stimulation, serving as a sham control
Change in Global Cognitive Function as Measured by the Mean Composite T-Score Derived from 14 Neuropsychological Tests
Global cognitive function will be assessed using the mean of the standardized T-scores from 14 neuropsychological tests: the MATRICS Consensus Cognitive Battery (MCCB; 9 subtests) plus 5 supplementary tests - the Wisconsin Card Sorting Test 64-Item Version (WCST-64), the Color Trails Test I and II, the Stroop Color-Word Test, and the Paced Auditory Serial Addition Task (PASAT). Raw scores from all 14 tests will be converted to standardized T-scores (population mean of 50, standard deviation of 10), adjusted for age, sex, education, and city of childhood and current residence. A single composite T-score will be calculated as the mean of the 14 test T-scores. Higher scores indicate better cognitive function.
Time frame: Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
Change in Synaptic Density as Measured by [18F]SV2A-PET Standardized Uptake Value Ratio (SUVR)
Synaptic density will be assessed using \[18F\]SV2A positron emission tomography (SV2A-PET). The outcome is the change in the standardized uptake value ratio (SUVR), calculated with the centrum semiovale (white matter) as the reference region. Higher SUVR values indicate greater synaptic density.
Time frame: Baseline and Follow-up (Day 40 ± 3)
Change in Psychotic Symptom Severity as Measured by the Positive and Negative Syndrome Scale (PANSS) Total Score
Psychiatric symptom severity will be assessed using the Positive and Negative Syndrome Scale (PANSS). The PANSS total score ranges from 30 to 210, with higher scores indicating more severe symptoms.
Time frame: Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
Change in Negative Symptom Severity as Measured by the Scale for the Assessment of Negative Symptoms (SANS) Total Score
Negative symptoms will be assessed using the Scale for the Assessment of Negative Symptoms (SANS). The SANS total score ranges from 0 to 125, with higher scores indicating more severe negative symptoms
Time frame: Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
Change in Treatment-Emergent Adverse Event Severity as Measured by the Treatment Emergent Symptom Scale (TESS) Total Score
Treatment-emergent adverse events will be assessed using the Treatment Emergent Symptom Scale (TESS), a 35-item clinician-rated scale. Each item is rated for severity on a 0-4 scale (0 = absent/not applicable, 4 = severe). The outcome is the change in TESS total severity score, with higher scores indicating greater adverse event burden.
Time frame: Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
Brain MRI Measures (High-Resolution T1-Weighted, Resting-State fMRI, Task-Based fMRI [n-back]，DTI)
Change in structural and functional MRI measures.
Time frame: Baseline, post-intervention, and Follow-up (Day 40 ± 3)
Change in Resting-State EEG Spectral Power
Resting-state electroencephalography (EEG) will be recorded with eyes closed. The outcome is the change in absolute spectral power (in μV²) in the delta (1-4 Hz), theta (4-8 Hz), alpha (8-12 Hz), beta (12-30 Hz), and gamma (30-48 Hz) frequency bands.
Time frame: Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
Change in Peripheral Blood Biomarker Concentrations
Peripheral blood samples will be collected for exploratory biomarker assessment. The outcome is the change in the concentration of selected peripheral blood biomarkers (e.g., inflammatory cytokines, neurotrophic factors, and other candidate analytes), reported in their respective units (e.g., pg/mL). Specific analytes will be determined and described in the results publication.
Time frame: Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
Incidence of Adverse Events Related to SD-aTBS
Adverse events recorded daily through spontaneous reporting and post-treatment inquiries during the intervention period
Time frame: Daily during the 10-day intervention period
Change in 40 Hz Auditory Steady-State Response (ASSR)
The auditory steady-state response (ASSR) will be elicited by 40 Hz click trains. The outcome is the change in phase-locking factor (inter-trial coherence) and evoked power at 40 Hz. Higher values indicate stronger 40 Hz neural synchronization.
Time frame: Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
Change in Mismatch Negativity (MMN) Amplitude
Mismatch negativity (MMN) will be recorded during an auditory oddball paradigm. The outcome is the change in MMN amplitude (in microvolts) at fronto-central electrodes (e.g., Fz). Larger (more negative) MMN amplitude indicates greater pre-attentive change detection.
Time frame: Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
Change in P300 Event-Related Potential Amplitude
The P300 event-related potential will be recorded during an auditory oddball paradigm. The outcome is the change in P300 amplitude (in microvolts) at midline electrodes (e.g., Cz, Pz). Larger P300 amplitude indicates better attentional/cognitive processing.
Time frame: Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
No study locations are listed for this record.
Plan to share: Yes — De-identified individual participant data (IPD) underlying the published results will be shared, including baseline demographic and clinical characteristics, cognitive and symptom assessment scores (MCCB, PANSS, SANS, TESS), and related outcome data. Identifiable imaging (MRI, EEG, SV2A-PET) and biomarker data will only be shared in de-identified form, subject to a data use agreement and approval by the study team, to protect participant privacy. Requests for IPD should be directed to the principal investigator
Supporting information: Study protocol, Statistical analysis plan
Time frame: After publication
Access criteria: De-identified individual participant data underlying the published results will be shared with qualified researchers who provide a methodologically sound proposal, subject to approval by the study team and execution of a data use agreement.
No publications or documents are linked to this record.
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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