The Efficacy of Combined HD-tDCS and iTBS in Treating Negative Symptoms of Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The change in Positive and Negative Syndrome Scale (PANSS) negative subscale score
研究概览
简要总结
Dysfunction of the dorsolateral prefrontal cortex (DLPFC) is central to the persistence of negative symptoms in schizophrenia. Both HD-tDCS and iTBS targeting the left DLPFC have shown therapeutic benefit. This trial will test the hypothesis that combining HD-tDCS with iTBS yields additive efficacy.
详细描述
Dysfunction of the left dorsolateral prefrontal cortex (DLPFC) is central to the persistence of negative symptoms in schizophrenia, an area of unmet therapeutic need. High-definition transcranial direct current stimulation (HD-tDCS) and intermittent theta burst stimulation (iTBS), an optimized form of repetitive transcranial magnetic stimulation (rTMS), have each demonstrated efficacy in alleviating negative symptoms when applied to the left DLPFC. However, meta-analyses indicate only moderate effect sizes for these interventions individually. Evidence suggests that combining iTBS with tDCS may enhance cortical plasticity beyond either technique alone, warranting trials to assess additive efficacy. This double-blind, randomized, sham-controlled study will test the hypothesis that combined HD-tDCS and iTBS produce superior therapeutic benefit for negative symptoms in schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with DSM-5 schizophrenia or schizoaffective disorder;
- •With a clinical presentation characterized by predominant negative symptoms, as determined by psychiatric assessment and a score of at least 20 on the Negative Symptoms Subscale of the Positive and Negative Syndrome Scale (PANSS);
- •Stable positive and negative symptoms for at least 4 weeks, as documented in medical records and confirmed by clinical judgment and psychiatric interview;
排除标准
- •Unstable medical conditions;
- •Current psychiatric comorbidity or active substance use disorder (except for tobacco use disorders);
- •Contraindications for MRI, tDCS or rTMS;
- •Pregnancy or breastfeeding at the time of enrollment;
- •History of meningitis, encephalitis, seizures, intracranial neoplasms or surgery, severe head injury or cerebrovascular disease, or a family history of seizures;
- •rTMS or tDCS treatment within the past 6 months as well as a history of electroconvulsive therapy (ECT);
- •Any skin lesion at the stimulation sites;
- •Patients receiving medications that significantly change the seizure threshold;
- •A history of suicidal behavior within the past 6 months, or symptom worsening and emergence of suicidal ideation during the screening period.
研究组 & 干预措施
active iTBS followed by active HD-tDCS
During the 3-week intervention phase, patients in this group will receive 2 sessions of active iTBS per working day for 2 weeks (totaling 20 sessions), followed by 2 sessions of active HD-tDCS per working day for 1 week (totaling 10 sessions).
干预措施: active iTBS followed by active HD-tDCS (Device)
sham iTBS followed by active HD-tDCS
During the 3-week intervention phase, patients in this group will receive 2 sessions of sham iTBS per working day for 2 weeks (totaling 20 sessions), followed by 2 sessions of active HD-tDCS per working day for 1 week (totaling 10 sessions).
干预措施: sham iTBS followed by active HD-tDCS (Device)
active iTBS followed by sham HD-tDCS
During the 3-week intervention phase, patients in this group will receive 2 sessions of active iTBS per working day for 2 weeks (totaling 20 sessions), followed by 2 sessions of sham HD-tDCS per working day for 1 week (totaling 10 sessions).
干预措施: active iTBS followed by sham HD-tDCS (Device)
sham iTBS followed by sham HD-tDCS
During the 3-week intervention phase, patients in this group will receive 2 sessions of sham iTBS per working day for 2 weeks (totaling 20 sessions), followed by 2 sessions of sham HD-tDCS per working day for 1 week (totaling 10 sessions).
干预措施: sham iTBS followed by sham HD-tDCS (Device)
结局指标
主要结局
The change in Positive and Negative Syndrome Scale (PANSS) negative subscale score
时间窗: Fifteen weeks
PANSS is a clinician-administered rating scale to measure the severity of psychopathological symptoms of the patients with schizophrenia spectrum disorder. The patient is rated from 1 to 7 on 30 different symptom items. All items scores are summed up to yield a total PANSS score, which ranges from 30 to 210. A higher score indicates greater psychopathological symptom severity. PANSS negative subscale has 7 items with its score ranging from 7 to 49. The changes in the PANSS negative subscale score immediately after the 3-week intervention (primary endpoint), as well as at one-month and three-month follow-ups, will be collected as the primary outcome.
次要结局
- The change in score of the Scale for the Assessment of Negative Symptoms (SANS)(Fifteen weeks)
- The change in score of Calgary Depression Rating Scale for Schizophrenia (CDSS)(Fifteen weeks)
- The change in the Personal and Social Performance scale (PSP) score(Fifteen weeks)
- The change in the score of the Beck Cognitive Insight Scale (BCIS)(Fifteen weeks)
- The change in the score of Schizophrenia Quality of Life Scale Revision Four (SQOLR4)(Fifteen weeks)
- The changes in the results of the Tower of London Drexel University Test 2nd Edition(Three weeks)
- The changes in the results of the Color Trails Test (CTT)(Three weeks)
- The changes in the results of the Stroop Color Word Test (SCWT)(Three weeks)
- The changes in indices of heart rate variability (HRV)(Three weeks)
- The changes in fNIRS features(Three weeks)
- The changes in resting-state fMRI features(Three weeks)
- The changes in resting-state EEG features(Three weeks)
- The changes in indices of heart rate variability (HRV) derived from R-R intervals of ECG signals(Three weeks)
研究者
Hsin-An Chang, MD
Attending psychiatrist
Tri-Service General Hospital (TSGH)