Efficacy and Safety of Individualized Sequential Accelerated Theta Burst Stimulation in Improving Cognitive Function in Schizophrenia
NCT07806877, Not applicable, Not yet recruiting, Central South University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Efficacy and Safety of Individualized Sequential Accelerated Theta Burst Stimulation in Improving Cognitive Function in Schizophrenia | ClinicalTrials.gov |
| NCT number | NCT07806877 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 60 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Central South University | ClinicalTrials.gov |
| Conditions | Schizophrenia / Schizoaffective Disorder, TMS, Cognitive, PET / MR | ClinicalTrials.gov |
| Interventions | Sequential Dual-Site Accelerated Theta Burst Stimulation (SD-aTBS), Sham Sequential Dual-Site Accelerated Theta Burst Stimulation | ClinicalTrials.gov |
| First posted | 2026-09-08 | ClinicalTrials.gov |
| Last updated | 2026-09-08 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Global Cognitive Function as Measured by the Mean Composite T-Score Derived from 14 Neuropsychological Tests | Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3) | 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. | ClinicalTrials.gov |
| Primary | Change in Synaptic Density as Measured by [18F]SV2A-PET Standardized Uptake Value Ratio (SUVR) | Baseline and Follow-up (Day 40 ± 3) | 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. | ClinicalTrials.gov |
| Secondary | Change in Psychotic Symptom Severity as Measured by the Positive and Negative Syndrome Scale (PANSS) Total Score | Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3) | 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. | ClinicalTrials.gov |
| Secondary | Change in Negative Symptom Severity as Measured by the Scale for the Assessment of Negative Symptoms (SANS) Total Score | Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3) | 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 | ClinicalTrials.gov |
| Secondary | Change in Treatment-Emergent Adverse Event Severity as Measured by the Treatment Emergent Symptom Scale (TESS) Total Score | Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3) | 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. | ClinicalTrials.gov |
| Secondary | Brain MRI Measures (High-Resolution T1-Weighted, Resting-State fMRI, Task-Based fMRI [n-back]，DTI) | Baseline, post-intervention, and Follow-up (Day 40 ± 3) | Change in structural and functional MRI measures. | ClinicalTrials.gov |
| Secondary | Change in Resting-State EEG Spectral Power | Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3) | 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. | ClinicalTrials.gov |
| Secondary | Change in Peripheral Blood Biomarker Concentrations | Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3) | 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. | ClinicalTrials.gov |
| Secondary | Incidence of Adverse Events Related to SD-aTBS | Daily during the 10-day intervention period | Adverse events recorded daily through spontaneous reporting and post-treatment inquiries during the intervention period | ClinicalTrials.gov |
| Secondary | Change in 40 Hz Auditory Steady-State Response (ASSR) | Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3) | 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. | ClinicalTrials.gov |
| Secondary | Change in Mismatch Negativity (MMN) Amplitude | Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3) | 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. | ClinicalTrials.gov |
| Secondary | Change in P300 Event-Related Potential Amplitude | Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3) | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Card Sorting Test (Berg) | Primary outcome | ConductCognition |
| Paced Visual Serial Addition Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| 1-Back Task | Secondary outcome | ConductCognition |
| 2-Back Task | Secondary outcome | ConductCognition |
| Oddball Target Detection | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)