Efficacy and Safety of Time Interference Stimulation on Cognitive Impairment Associated With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- changes on MCCB scores
研究概览
简要总结
This study aims to evaluate the efficacy and safety of TIS targeting the hippocampus in ameliorating cognitive impairment associated with schizophrenia (CIAS). Participants will receive TIS twice a day for 2 weeks. Their clinical data, including the baseline clinical symptom scale score, cognitive function, and MRI data, will be collected at baseline and at the end of the 2-week intervention.
详细描述
Cognitive impairment associated with schizophrenia (CIAS) remains a therapeutic challenge, as conventional antipsychotics and depth-limited neurostimulation (NIBS) fail to address the subcortical dysregulation that drives cognitive dysfunction. Temporal Interference Stimulation (TIS) overcomes these biophysical limitations by using intersecting high-frequency electric fields to non-invasively target deep structures such as the hippocampus with great spatial accuracy. Due to its potential to enhance the synchronization between the hippocampus and the prefrontal cortex, TIS offers a new prospect for treating CIAS.
This single-arm, open-label trial will evaluate the efficacy of hippocampal-targeted TIS in patients with schizophrenia. Participants will undergo a 10-day intervention (twice daily) and will be assessed using clinical, cognitive (MCCB), and neuroimaging (rs-fMRI) tests at baseline and post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age 18-50 years old;
- •meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5) diagnostic criteria;
- •the diagnosis of schizophrenia is confirmed by the Structured Clinical Interview for DSM-5 (SCID-5);
- •the disease duration does not exceed 8 years;
- •1-2 antipsychotic drugs are taken, and the treatment dose of antipsychotic drugs was stable for at least 1 week before enrollment. Mood stabilizers, antidepressants, and excessive benzodiazepines (lorazepam when 2 doses exceeded 2 mg/d) are not allowed;
- •The type of antipsychotic drugs remains unchanged during treatment, and the dose is adjusted by no more than 25%;
- •Impaired functioning in daily activities;
- •The Global Deficit Score (GDS) for the MATRICS Consensus Cognitive Battery (MCCB) reaches 0.5 or above;
- •Agree to participate in this study and provide written informed consent
排除标准
- •Presence of other psychiatric comorbidities, intellectual disability, obvious mood symptoms, or substance use disorders (other than caffeine and/or tobacco);
- •with clear drug-induced extrapyramidal reaction;
- •A history of seizures, meningitis, or encephalitis;
- •with contraindications to transcranial electrical stimulation;
- •History of intracranial tumors or surgery;
- •history of severe head trauma;
- •have received other regimens of electrical or magnetic therapy in 1 month before enrollment.
研究组 & 干预措施
TI
TI group will be administered temporal interference stimulation
干预措施: temporal interference stimulation (Device)
结局指标
主要结局
changes on MCCB scores
时间窗: Baseline, after 2-week intervention
The MATRICS Consensus Cognitive Battery (MCCB) can be used for cognitive assessment of schizophrenia, bipolar disorder, and other neuropsychiatric diseases. The MCCB covers nine cognitive domains, including attention, information processing speed, verbal learning and memory, visual learning and memory, spatial working memory, reasoning, problem solving, social cognition, executive function, and fine motor skills. The working memory domain does not include verbal working memory because the Chinese language would not make feasible the inclusion of the LNS test.
次要结局
- Changes in Positive and Negative Symptom Scale (PANSS) scores(Baseline, after 2-week intervention)
- Change in Scale for Assessment of Negative Symptoms (SANS) score(Baseline, after 2-week intervention)
- Changes in brain function(Baseline, after 2-week intervention)
- changes on behavioral performance(Baseline, after 2-week intervention)
- changes of global function.(Baseline, after 2-week intervention)
- Changes in Psychotic symptom rating scales (PSYRATS) score(Baseline, after 2-week intervention)
- adverse event incidences(Day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10.)
研究者
Renrong Wu
Professor
Central South University