Efficacy and Safety of Individualized Sequential Accelerated Theta Burst Stimulation in Improving Cognitive Function in Schizophrenia
2026년 9월 1일 업데이트: Renrong Wu, Central South University
Sequential Dual-Site Accelerated Theta Burst Stimulation Targeting the Frontoparietal and Default Mode Networks for Cognitive Impairment in Schizophrenia: A Randomized, Double-Blind, Sham-Controlled Study
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
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
60
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Xingjie Peng, MD
- 전화번호: +86 151 1113 0170
- 이메일: 992348023@qq.com
연구 연락처 백업
- 이름: Renrong Wu, MD
- 전화번호: +86 158 7417 9855
- 이메일: wurenrong@csu.edu.cn
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Age 18-35 years.
- Meets the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by the Structured Clinical Interview for DSM-5 (SCID-5).
- Duration of illness ≤ 8 years.
- Taking no more than 2 antipsychotic medications, with a stable antipsychotic dose for at least 4 weeks prior to enrollment, and no expected change in the medication regimen throughout the treatment and follow-up period.
（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 informed consent.
Exclusion Criteria:
- Current or lifetime co-occurrence of any other DSM-5 psychiatric disorder.
- Concurrent use of mood stabilizers, antidepressants, or excessive benzodiazepines (lorazepam equivalent > 2 mg/day).
- Presence of severe or acute physical illness, including a history of epilepsy, traumatic brain injury, intracranial space-occupying or infectious disease, acute cardiovascular or cerebrovascular disease, acute respiratory disease, or acute hematologic disease.
- Any contraindication to transcranial magnetic stimulation (TMS), PET scanning, or magnetic resonance imaging (MRI).
- Receipt of any other electrical or stimulation therapy within 3 months prior to enrollment.
- Current use of medications known to interact with SV2A (e.g., levetiracetam, loratadine, quinine).
Withdrawal Criteria
- Occurrence of a serious adverse event possibly related to the intervention (e.g., seizure, symptom relapse requiring immediate hospitalization).
- Onset of a new severe illness during the study (e.g., cardiovascular event, severe infection, severe hepatic or renal dysfunction).
- A change in the antipsychotic medication regimen during the study - including a dose adjustment of ≥ 25%, or a switch to a different antipsychotic medication.
- Poor adherence, inability to complete the full intervention, failure to return for follow-up as required, or inability to cooperate with the examinations and assessments.
- Pregnancy.
- Voluntary withdrawal of informed consent by the participant.
- Any other condition judged by the investigator to render the participant unable to complete the study or likely to affect the study results.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: active SD-TBS group
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.
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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.
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가짜 비교기: sham SD-TBS group
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.
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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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Global Cognitive Function as Measured by the Mean Composite T-Score Derived from 14 Neuropsychological Tests
기간: Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
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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.
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Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
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Change in Synaptic Density as Measured by [18F]SV2A-PET Standardized Uptake Value Ratio (SUVR)
기간: Baseline and Follow-up (Day 40 ± 3)
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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.
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Baseline and Follow-up (Day 40 ± 3)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Psychotic Symptom Severity as Measured by the Positive and Negative Syndrome Scale (PANSS) Total Score
기간: Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
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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.
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Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
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Change in Negative Symptom Severity as Measured by the Scale for the Assessment of Negative Symptoms (SANS) Total Score
기간: Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
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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
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Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
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Change in Treatment-Emergent Adverse Event Severity as Measured by the Treatment Emergent Symptom Scale (TESS) Total Score
기간: Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
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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.
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Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
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Brain MRI Measures (High-Resolution T1-Weighted, Resting-State fMRI, Task-Based fMRI [n-back]，DTI)
기간: Baseline, post-intervention, and Follow-up (Day 40 ± 3)
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Change in structural and functional MRI measures.
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Baseline, post-intervention, and Follow-up (Day 40 ± 3)
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Change in Resting-State EEG Spectral Power
기간: Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
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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.
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Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
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Change in Peripheral Blood Biomarker Concentrations
기간: Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
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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.
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Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
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Incidence of Adverse Events Related to SD-aTBS
기간: Daily during the 10-day intervention period
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Adverse events recorded daily through spontaneous reporting and post-treatment inquiries during the intervention period
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Daily during the 10-day intervention period
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Change in 40 Hz Auditory Steady-State Response (ASSR)
기간: Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
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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.
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Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
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Change in Mismatch Negativity (MMN) Amplitude
기간: Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
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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.
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Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
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Change in P300 Event-Related Potential Amplitude
기간: Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
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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.
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Baseline, immediately after the intervention (Day 10), and at Follow-up (Day 40 ± 3)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Renrong Wu, Second Xiangya Hospital of Central South University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 30일
기본 완료 (추정된)
2028년 9월 30일
연구 완료 (추정된)
2028년 9월 30일
연구 등록 날짜
최초 제출
2026년 8월 27일
QC 기준을 충족하는 최초 제출
2026년 9월 1일
처음 게시됨 (실제)
2026년 9월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 1일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- LYG20260143
- 82325020 (기타 보조금/기금 번호: National Natural Science Foundation of China)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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
IPD 공유 기간
After publication
IPD 공유 액세스 기준
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.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .