High-Dose Spaced Bilateral tDCS for Late-Life Depression: Open-Label Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Treatment Tolerability
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
- Treatment
- 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 Structured Clinical Interview for DSM-5 (SCID-5);
- •score of 16 or higher on the Quick Inventory of Depressive Symptomology-Clinician Rated (QIDS-C) at screening;
- •stable antidepressant regimen for at least four weeks prior to enrollment, if applicable;
- •willingness and capacity to provide informed consent;
- •Clinical Dementia Rating scale of 0 or 0.
- •availability of an informant who has sufficient knowledge of the participant's daily functioning as ascertained by the study team.
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;
- •depressive disorder due to a medical condition;
- •psychotic depression;
- •history of seizures or epilepsy;
- •bipolar disorder;
- •psychotic disorders;
- •severe personality disorder;
- •active substance use disorder within the past six months or history of substance induced mood or psychotic disorder;
- •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;
- •a clinically established diagnosis of dementia as reported in the participant's health record or scoring 1 or above on CDR;
- •medically unstable in the clinical opinion of the principal investigators.
研究组 & 干预措施
tDCS in older adults with LLD
干预措施: High-intensity (6 mA) transcranial direct current stimulation (tDCS) (Device)
结局指标
主要结局
Treatment Tolerability
时间窗: 6 weeks
The proportion of participants who tolerate 6mA across the entire treatment course without dose-limiting adverse events.
Treatment Feasibility
时间窗: 6 weeks
Completion Rate: The proportion of enrolled participants who complete 21 of 27 treatments over a 3-week period.
Completion Rate
时间窗: 6 weeks
The proportion of enrolled participants who complete at least 7 of 9 treatment days.
Target dose achievement
时间窗: 6 weeks
The proportion of participants who reach their calculated target dose without dose-limiting intolerance.
Session completion
时间窗: 6 weeks
The proportion of scheduled sessions completed across all participants.
Adverse event profile
时间窗: 6 weeks
Including incidence, severity, and time course of adverse events.
次要结局
- Mean change in IDS-C score(6 weeks)
- Depression Response Rate(6 weeks)
- Target engagement(6 weeks)
- Clinical - HDRS-17(6 weeks)
- Correlation of Stimulation Dose With Change in HDRS 17 Scores(6 weeks)
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