Efficacy and Mechanisms of Transcranial Alternating Current Stimulation in Improving Working Memory in Patients With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Working Memory Accuracy
研究概览
简要总结
This study is a randomized, single-blind, sham-controlled crossover trial enrolling 30 schizophrenia patients, each receiving one active and one sham tACS session (7-day washout), targeting P3/P4 at individual alpha frequency (2mA, 30min) during a working memory task, with accuracy and reaction time as primary outcomes, alongside EEG and neurophysiological measures, to test the efficacy and mechanisms of individualized alpha-tACS on working memory.
详细描述
This study is a randomized, single-blind, sham-controlled, crossover exploratory trial that plans to enroll 30 inpatients with schizophrenia, randomized 1:1 into two groups, with all participants receiving one active and one sham tACS session in a crossover manner separated by a 7-day washout. Stimulation targets the parietal P3/P4 sites at individual alpha frequency, with an intensity of 2 mA and a duration of 30 minutes per session, delivered concurrently with a working memory task (SIRP). Primary outcomes are SIRP accuracy and reaction time, with concurrent task-state EEG recording, along with assessments of clinical symptoms, cognitive function, and neurophysiological markers including ASSR, MMN, and P300. The study aims to explore the efficacy and underlying neural mechanisms of individualized alpha-tACS in improving working memory 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
- Single (Participant)
盲法说明
This study used a single-blind design, with participants blinded to treatment allocation (active vs. sham). The device operator was not blinded due to differing parameter settings between active and sham stimulation, but was not involved in recruitment, clinical assessment, or data analysis. To maintain blinding integrity, participants were prohibited from discussing treatment-related sensations with the operator or among themselves. The sham procedure mimicked the initial scalp sensation of active stimulation to enhance blinding credibility.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-50 years, meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for schizophrenia, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5).
- •Spatial span T-score <40 on the MATRICS Consensus Cognitive Battery (MCCB).
- •Taking 1-2 antipsychotic medications, with stable dosage for at least 1 week prior to enrollment. No use of mood stabilizers, antidepressants, or excessive benzodiazepines (lorazepam equivalent >2 mg/day). The type and dosage of antipsychotic medications remain unchanged during the treatment period.
- •Impaired functioning in daily activities.
- •Willing to participate in this study and provide written informed consent.
排除标准
- •Previously diagnosed with or comorbid any other DSM-5 mental disorder besides schizophrenia.
- •Presence of significant mood symptoms or substance use disorder (other than caffeine and/or tobacco).
- •Presence of any contraindication to transcranial alternating current stimulation (tACS).
- •Received other forms of electrical or magnetic stimulation therapy within 1 month prior to enrollment.
- •History or current presence of any major physical illness, neurological disorder, or traumatic brain injury that may affect brain structure or function.
- •Pregnant or breastfeeding women, or women planning to become pregnant during the study period.
研究组 & 干预措施
sham group
sham stimulation
干预措施: sham stimulation (Device)
active group
transcranial alternating current stimulation
干预措施: transcranial alternating current stimulation (Device)
结局指标
主要结局
Working Memory Accuracy
时间窗: Day 1 (baseline, prior to first intervention); within 15 minutes after Session 1; Day 9 (prior to second intervention, after 7-day washout); within 15 minutes after Session 2.
Assessment of task accuracy on the Sternberg Item Recognition Paradigm (SIRP). Participants are required to judge whether a probe stimulus belongs to a previously memorized set, with memory set sizes of 1 and 5. The outcome is measured as the percentage of correct responses (0-100%) across all trials, with higher scores indicating better working memory performance.
Working Memory Reaction Time
时间窗: Day 1 (baseline, prior to first intervention); within 15 minutes after Session 1; Day 9 (prior to second intervention, after 7-day washout); within 15 minutes after Session 2.
Assessment of response speed on the Sternberg Item Recognition Paradigm (SIRP). Participants are required to judge whether a probe stimulus belongs to a previously memorized set, with memory set sizes of 1 and 5. The outcome is measured as the mean response latency for correct responses only, calculated from stimulus onset to the participant's button press, with shorter times indicating faster processing speed.
次要结局
- Changes in MCCB Performance(Baseline, on the day after each of the two interventions)
- Changes in Positive and Negative Symptom Scale (PANSS) Scores(Before and one week after each of the two interventions.)
- Changes in Scale for the Assessment of Negative Symptoms (SANS) Scores(Before and one week after each of the two interventions.)
- Changes in Calgary Depression Scale for Schizophrenia (CDSS) Scores(Before and one week after each of the two interventions.)
- Hallucination and Delusion Visual Analog Scale (HD-VAS) Score(Within 15 minutes after completion of Session 1; within 15 minutes after completion of Session 2.)
- Changes in Brain Function(Baseline, on the day after each of the two interventions.)
- Changes in Neuroelectrophysiological Signals(Baseline, 30 minutes after each of the two interventions.)
- Changes in 40Hz Auditory Steady-State Response (40Hz-ASSR)(Baseline, 30 minutes after each of the two interventions.)
- Changes in Mismatch Negativity (MMN)(Baseline, 30 minutes after each of the two interventions.)
- Changes in P300 Event-Related Potential(Baseline, 30 minutes after each of the two interventions.)
研究者
Renrong Wu
Professor
Second Xiangya Hospital of Central South University