NCT07657234尚未招募不适用
High-Dose Spaced Bilateral tDCS for Late-Life Depression: Open-Label Pilot Study
Andre Russowsky Brunoni1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年8月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
The purpose of this research study is to determine the effectiveness of Transcranial direct current stimulation (tDCS) therapy in the treatment of participants with Late-life depression (LLD).
The study will evaluate feasibility, safety, and tolerability of high-dose (6mA) bilateral tDCS delivered as three daily sessions, 3 times a week, for 3 weeks in older adults (60 y/o and older) with late-life depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following criteria:
- •age 60 years or older;
- •diagnosis of unipolar major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by the Mini International Neuropsychiatric Interview (MINI);
- •score of 17 or higher on the 17-item Hamilton Depression Rating Scale (HDRS-17) at screening;
- •stable antidepressant regimen for at least four weeks prior to enrollment, if applicable;
- •capacity to provide informed consent;
- •Clinical Dementia Rating scale of 0 or 0.5.
排除标准
- •Participants meeting any of the following criteria will be excluded:
- •contraindications to tDCS including metallic cranial implants, skin conditions at electrode sites (eczema, open wounds, burns, lesions), or history of adverse reaction to tDCS;
- •contraindications to magnetic resonance imaging (MRI) including pacemaker, cochlear implants, ferromagnetic implants, or claustrophobia;
- •history of seizures or epilepsy;
- •bipolar disorder, psychotic disorders, or severe personality disorder;
- •dementia or MoCA score below 17;
- •substance use disorder within the past six months;
- •neuromodulation treatment including electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), tDCS, or vagus nerve stimulation (VNS) within the past six months;
- •active suicidal ideation with plan or intent requiring a higher level of care;
- •concurrent use of medications that substantially lower seizure threshold;
研究者
Andre Russowsky Brunoni
Professor and Chief of the Division of Interventional Psychiatry Department of Psychiatry UT Southwestern Medical Center Peter O'Donnell Jr. Brain Institute
University of Texas Southwestern Medical Center
研究点 (1)
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