HRV-Guided tDCS: Integrating A Biomarker For Clinical Utility
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Average HR Measured Using i-HR Data Logger
研究概览
简要总结
This technology development project will be informed and guided by initial data collection of human subject data. For this purpose, the investigators will recruit n=100 people with mild to moderate depression in a double-blinded, parallel-arm, sham-controlled data collection period administered at home and using the investigator's remotely supervised (RS) tDCS protocol. Enrolled participants will complete 10 days of 30-minute tDCS (2.0, DLPFC left anodal) using the RS-tDCS protocol. During each daily session, standard HR and impedance-based HR (i-HR), obtained from the tDCS headset, will be collected to identify a possible marker of response to tDCS in depression. Participants will be randomized 2:1 to active vs. sham tDCS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- •Mild to moderate depression (Beck Depression Inventory(BDI)-II 14-28)
- •Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-V-TR) Depressive episode
- •Wide Range Achievement Test (WRAT)-4th Reading Recognition subtest standard score >85
排除标准
- •Primary neurologic, psychiatric (e.g., multiple sclerosis, stroke, Parkinson's disease, spinal cord injury, intracranial mass, traumatic brain injury (TBI), epilepsy, mild cognitive impairment (MCI), or dementia), or major medical disorder (e.g., history of myocardial infarction, diabetes, thyroid disease, arrhythmia, atrial fibrillation) (medical history review)
- •DSM-V-TR bipolar depression, psychotic disorder, or alcohol or substance use disorder (M.I.N.I.)
- •Active or high suicidality risk (Columbia-Suicide Severity Rating Scale, C-SSRS), or otherwise judged as inappropriate by the study clinicians
- •History of a heart transplant, presence of permanent pacemaker implant or Left Ventricular Assist Device
- •Use of certain medications that can affect heart rate variability, such as beta-blockers, calcium channel blockers, or cardiac glycosides
- •Use of antidepressant, antipsychotic, anxiolytic, or stimulant medications
- •Pregnant or planning pregnancy during the study period
- •Seizure disorder or recent (<5 years) seizure history
- •Presence of metal objects in the head/neck
- •Any skin disorder or skin sensitive area near stimulation locations
结局指标
主要结局
Average HR Measured Using i-HR Data Logger
时间窗: Up to Week 4
HR will be measured using an impedance-based HR (i-HR) data logger attached to the Mini-CT tDCS device at each daily tDCS session.
Average Heart Rate (HR) Measured Using Polar H10 Chest Monitor
时间窗: Up to Week 4
HR will be measured using Polar H10 Chest Monitor at each daily tDCS session.
次要结局
- Change in Positive and Negative Affect Schedule (PANAS-SF): Positive Affect Score(Baseline, End of Intervention (Up to Week 4))
- Change in State-Trait Anxiety Inventory for Adults (STAI): Trait Score(Baseline, End of Intervention (Up to Week 4))
- Change in State-Trait Anxiety Inventory for Adults (STAI): State Score(Baseline, End of Intervention (Up to Week 4))
- Change in Positive and Negative Affect Schedule (PANAS-SF): Negative Affect Score(Baseline, End of Intervention (Up to Week 4))
- Change in Montgomery Ӓsberg Depression Rating Scale (MADRS) Score(Baseline, End of Intervention (Up to Week 4))