Modulating Alpha-connectivity in Patients with Active Suicidal Ideation Using Transcranial Alternating Current Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- EEG alpha functional connectivity (phase synchronization)
研究概览
简要总结
The goal of this clinical trial is to determine whether modulating default mode network (DMN) alpha connectivity using transcranial alternating current stimulation (tACS) can reduce rumination and, in turn, mitigate feelings of entrapment and suicidal ideation in individuals with active suicidal ideation and depression.
The main questions it aims to answer are:
- Is personalized tACS stimulation of the DMN associated with reduced rumination 24 hours after stimulation?
- Does a reduction in rumination result in lower feelings of entrapment and suicidal ideation?
- Does personalized tACS stimulation of the DMN lead to a reduction of DMN alpha connectivity?
Researchers will compare active tACS stimulation to sham stimulation to assess whether modulating alpha connectivity has a specific effect on rumination, entrapment, suicidal ideation, and DMN alpha connectivity.
Participants will:
- Receive either active or sham tACS stimulation during stimulation sessions, but all participants will receive active tACS at least once.
- Complete self-report measures of rumination, entrapment, and suicidal ideation before and after stimulation.
- Undergo EEG recordings to assess changes in DMN alpha connectivity.
This clinical trial will be preceded by a pilot study in healthy participants with an anticipated completion of data collection in August 2025.
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, Investigator, Outcomes Assessor)
盲法说明
Investigators assessing primary electroencephalography (EEG) outcomes will also be blinded to the assigned study arm.
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
- •Active suicidal ideation defined by a score ≥3 on item #10 of the Montgomery-Asberg Depression Rating Scale (MADRS) and a combined score of ≥2 on items #4 + #5 of the Beck Scale for Suicide Ideation (BSS)
- •Clinical diagnosis of a mild to severe depressive episode without psychotic symptoms
- •Voluntary patients at inpatient, outpatient, or day-clinic units of mental health care settings in the greater Zurich area
- •Aged 18-65 years
- •Fluent in German
- •Ability to give written informed consent
排除标准
- •Mental disorders due to known physiological conditions
- •Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders
- •Intellectual disabilities
- •Concurrent vagus nerve stimulation, transcranial magnetic stimulation, electro-convulsive therapy, or treatment with nitrous oxide
- •Pregnancy or breast-feeding
- •Chronic migraines
- •Metal implants or any other factor that - in the investigators' judgment - would unduly affect patient safety or compliance during this study
结局指标
主要结局
EEG alpha functional connectivity (phase synchronization)
时间窗: Pre-stimulation to post-stimulation at visit 2 (up to 1 hour)
The primary outcome measure will be changes in EEG alpha functional connectivity between pre- and post-stimulation at visit 2 (stimulation visit 1) in the active versus sham group (between-person comparison). EEG alpha functional connectivity will also be assessed at visit 4 (stimulation visit 2). Allowing for between- and within-person comparisons as secondary outcomes.
Response style questionnaire (RSQ-10D)
时间窗: Visit 2 to visit 3 (24 hours)
The primary outcome will be changes in rumination between visit 2 (pre-stimulation) and visit 3 (24 hours post-stimulation) in the active versus sham group (between-person comparison). Rumination will also be assessed at visit 4 and visit 5, allowing for between- and within-person comparisons as secondary outcome measures. The RSQ-10D measures two facets of rumination: brooding and reflection with 5 items each. Scores per facet range from 5 to 20 with higher scores indicating higher rumination.
次要结局
- Beck Scale for Suicide Ideation (BSS)(Visits 2-5 (24 hours))
- Clinical Global Impression of Suicidality (CGI-SS-R)(Visits 2 & 4 (up to 1 hour))
- Montgomery-Asberg Depression Rating Scale (MADRS)(Visits 2-5 (24 hours))
- Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I)(Visits 2 & 4 (up to 1 hour))
- Suicidal Intent Visual Analogue Scale (S-VAS)(Visits 2 & 4 (up to 1 hour))
- Beck Depression Inventory (BDI-II)(Visits 2-5 (24 hours))
- Short Defeat and Entrapment Scale (SDES)(Visits 2-5 (24 hours))
研究者
Sebastian Olbrich
Prof. Dr. med.
University of Zurich