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心率变异性 (HRV) 引导经颅直流电刺激 (tDCS)

2026年9月24日 更新者：NYU Langone Health

HRV 引导的 tDCS：整合生物标志物以实现临床应用

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • New York
      • New York、New York、美国、10017
        • 招聘中
        • NYU Langone Health

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：随机化
  • 介入模型：单组作业
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Active tDCS

Participants randomized to the Active tDCS arm will complete 10 sessions of 30-minute active remotely supervised (RS)-tDCS with chest strap and impedance-based HRV data collection over the course of approximately 2-4 weeks.
设备：Active Transcranial Direct Current Stimulation (tDCS)

tDCS will be delivered using the 1x1 Mini CT tDCS device. For active tDCS, the device is programmed to ramp up to 2.0 mA (for 30 seconds), provide constant current throughout the session (29 minutes), and then ramp down (for 30 seconds) at the end. Participants will receive 10 sessions of tDCS over the course of this study on weekdays (M-F).
假比较器：Sham tDCS

Participants randomized to the Active tDCS arm will complete 10 sessions of 30-minute sham RS-tDCS with chest strap and impedance-based HRV data collection over the course of approximately 2-4 weeks.
设备：Sham Transcranial Direct Current Stimulation (tDCS)

Sham tDCS will be delivered using the 1x1 Mini CT tDCS device. For sham tDCS, the device is programmed to ramp up to 2.0 mA (for 30 seconds) followed by a ramp down (30 seconds), with no current delivery for 28 minutes, and then ramp up (for 30 seconds) and down (for 30 seconds) at the end. Participants will receive 10 sessions of sham tDCS over the course of this study on weekdays (M-F).

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Average Heart Rate (HR) Measured Using Polar H10 Chest Monitor
大体时间：Up to Week 4

HR will be measured using Polar H10 Chest Monitor at each daily tDCS session.
Up to Week 4
Average HR Measured Using i-HR Data Logger
大体时间：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.
Up to Week 4

次要结果测量

结果测量
措施说明
大体时间
Change in Montgomery Ӓsberg Depression Rating Scale (MADRS) Score
大体时间：Baseline, End of Intervention (Up to Week 4)

MADRS is a 10-item assessment of severity of depressive episodes in patients with mood disorders. Each item is rated on a scale from 0-6. The total score is the sum of responses and ranges from 0-60; higher scores indicate greater severity of depressive episodes.
Baseline, End of Intervention (Up to Week 4)
Change in State-Trait Anxiety Inventory for Adults (STAI): State Score
大体时间：Baseline, End of Intervention (Up to Week 4)

STAI is a 40-item questionnaire measuring state and trait anxiety. Each item is rated on a 4-point Likert scale. The range of possible scores for state anxiety ranges from a minimum score of 20 to a maximum score of 80; higher scores indicate greater state anxiety.
Baseline, End of Intervention (Up to Week 4)
Change in State-Trait Anxiety Inventory for Adults (STAI): Trait Score
大体时间：Baseline, End of Intervention (Up to Week 4)

STAI is a 40-item questionnaire measuring state and trait anxiety. Each item is rated on a 4-point Likert scale. The range of possible scores for trait anxiety ranges from a minimum score of 20 to a maximum score of 80; higher scores indicate greater trait anxiety.
Baseline, End of Intervention (Up to Week 4)
Change in Positive and Negative Affect Schedule (PANAS-SF): Positive Affect Score
大体时间：Baseline, End of Intervention (Up to Week 4)

PANAS-SF is a self-report questionnaire that consists of two 10-item scales (20 items total) to measure both positive and negative affect. Each item is rated on a scale from 1 (very slightly or not at all) to 5 (extremely). The total positive affect score is the sum of affect item responses and ranges from 10 - 50; higher scores represent higher levels of positive affect.
Baseline, End of Intervention (Up to Week 4)
Change in Positive and Negative Affect Schedule (PANAS-SF): Negative Affect Score
大体时间：Baseline, End of Intervention (Up to Week 4)

PANAS-SF is a self-report questionnaire that consists of two 10-item scales (20 items total) to measure both positive and negative affect. Each item is rated on a scale from 1 (very slightly or not at all) to 5 (extremely). The total negative affect score is the sum of negative item responses and ranges from 10 - 50; lower scores represent lower levels of negative affect.
Baseline, End of Intervention (Up to Week 4)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

NYU Langone Health

合作者

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

调查人员

  • 首席研究员：Giuseppina Pilloni, PhD、NYU Langone Health

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年1月2日

初级完成 (估计的)

2027年11月1日

研究完成 (估计的)

2027年11月1日

研究注册日期

首次提交

2024年6月7日

首先提交符合 QC 标准的

2024年6月7日

首次发布 (实际的)

2024年6月12日

研究记录更新

最后更新发布 (实际的)

2026年9月25日

上次提交的符合 QC 标准的更新

2026年9月24日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 24-00536

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Giuseppina.Pilloni@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD 共享时间框架

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD 共享访问标准

The investigator who proposes to use the data will be granted access upon reasonable request. Requests should be directed to Giuseppina.Pilloni@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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