Frequency- and Intensity-Dependent After-Effects of High-Definition Transcranial Alternating Current Stimulation on Resting-State Electroencephalography
2026年8月29日 更新者：Haifeng Jiang、Shanghai Mental Health Center
Frequency- and Intensity-Dependent After-Effects of High-Definition Transcranial Alternating Current Stimulation on Resting-State Electroencephalography in Patients With Auditory Hallucinations and Healthy Controls
This study aims to investigate the after-effects of high-definition transcranial alternating current stimulation (HD-tACS) with varying parameters on resting-state brain activity in patients with schizophrenia experiencing auditory hallucinations.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
36
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。
学习地点
-
-
-
Fuyang、中国
- Fuyang Mental Heath Center
-
-
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
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- Age 18 to 65 years;
- Meet the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
- Adequate verbal communication skills;
- At least one auditory hallucination episode within the past week;
- Willing to participate in the study and able to complete all trial procedures.
Exclusion Criteria:
- History of neurological disorders, severe physical illness, traumatic brain injury, or craniotomy;
- History of epileptic seizures or other neuropsychiatric disorders;
- At risk for suicide, self-injury, or impulsive behavior.
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：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：0.4mA-10Hz HD-tACS
For 0.4mA-10Hz HD-tACS prevention, we will stimulate the personalized left or right temporal lobe channel at 10 Hz and 0.4mA.
|
The active intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
Stimulation is administered for 90 seconds per condition, with the frequency and current intensity set according to the experimental protocol.
A 10-second ramp-up and a 5-second ramp-down period are included in each stimulation condition.
The stimulus waveform is sinusoidal.
Stimulation is delivered using saline-soaked sponge electrodes.
Electrode impedance is maintained below 10 kΩ throughout the stimulation session.
|
|
实验性的：0.4mA-20Hz HD-tACS
For 0.4mA-20Hz HD-tACS prevention, we will stimulate the personalized left or right temporal lobe channel at 20 Hz and 0.4mA.
|
The active intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
Stimulation is administered for 90 seconds per condition, with the frequency and current intensity set according to the experimental protocol.
A 10-second ramp-up and a 5-second ramp-down period are included in each stimulation condition.
The stimulus waveform is sinusoidal.
Stimulation is delivered using saline-soaked sponge electrodes.
Electrode impedance is maintained below 10 kΩ throughout the stimulation session.
|
|
实验性的：0.4mA-40Hz HD-tACS
For 0.4mA-40Hz HD-tACS prevention, we will stimulate the personalized left or right temporal lobe channel at 20 Hz and 0.4mA.
|
The active intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
Stimulation is administered for 90 seconds per condition, with the frequency and current intensity set according to the experimental protocol.
A 10-second ramp-up and a 5-second ramp-down period are included in each stimulation condition.
The stimulus waveform is sinusoidal.
Stimulation is delivered using saline-soaked sponge electrodes.
Electrode impedance is maintained below 10 kΩ throughout the stimulation session.
|
|
实验性的：0.4mA-140Hz HD-tACS
For 0.4mA-140Hz HD-tACS prevention, we will stimulate the personalized left or right temporal lobe channel at 10 Hz and 0.4mA.
|
The active intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
Stimulation is administered for 90 seconds per condition, with the frequency and current intensity set according to the experimental protocol.
A 10-second ramp-up and a 5-second ramp-down period are included in each stimulation condition.
The stimulus waveform is sinusoidal.
Stimulation is delivered using saline-soaked sponge electrodes.
Electrode impedance is maintained below 10 kΩ throughout the stimulation session.
|
|
实验性的：1mA-10Hz HD-tACS
For 1mA-10Hz HD-tACS prevention, we will stimulate the personalized left or right temporal lobe channel at 10 Hz and 0.4mA.
|
The active intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
Stimulation is administered for 90 seconds per condition, with the frequency and current intensity set according to the experimental protocol.
A 10-second ramp-up and a 5-second ramp-down period are included in each stimulation condition.
The stimulus waveform is sinusoidal.
Stimulation is delivered using saline-soaked sponge electrodes.
Electrode impedance is maintained below 10 kΩ throughout the stimulation session.
|
|
实验性的：1mA-20Hz HD-tACS
For 1mA-20Hz HD-tACS prevention, we will stimulate the personalized left or right temporal lobe channel at 10 Hz and 0.4mA.
|
The active intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
Stimulation is administered for 90 seconds per condition, with the frequency and current intensity set according to the experimental protocol.
A 10-second ramp-up and a 5-second ramp-down period are included in each stimulation condition.
The stimulus waveform is sinusoidal.
Stimulation is delivered using saline-soaked sponge electrodes.
Electrode impedance is maintained below 10 kΩ throughout the stimulation session.
|
|
实验性的：1mA-40Hz HD-tACS
For 1mA-40Hz HD-tACS prevention, we will stimulate the personalized left or right temporal lobe channel at 10 Hz and 0.4mA.
|
The active intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
Stimulation is administered for 90 seconds per condition, with the frequency and current intensity set according to the experimental protocol.
A 10-second ramp-up and a 5-second ramp-down period are included in each stimulation condition.
The stimulus waveform is sinusoidal.
Stimulation is delivered using saline-soaked sponge electrodes.
Electrode impedance is maintained below 10 kΩ throughout the stimulation session.
|
|
实验性的：1mA-140Hz HD-tACS
For 1mA-140Hz HD-tACS prevention, we will stimulate the personalized left or right temporal lobe channel at 10 Hz and 0.4mA.
|
The active intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
Stimulation is administered for 90 seconds per condition, with the frequency and current intensity set according to the experimental protocol.
A 10-second ramp-up and a 5-second ramp-down period are included in each stimulation condition.
The stimulus waveform is sinusoidal.
Stimulation is delivered using saline-soaked sponge electrodes.
Electrode impedance is maintained below 10 kΩ throughout the stimulation session.
|
|
实验性的：2mA-10Hz HD-tACS
For 2mA-10Hz HD-tACS prevention, we will stimulate the personalized left or right temporal lobe channel at 10 Hz and 0.4mA.
|
The active intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
Stimulation is administered for 90 seconds per condition, with the frequency and current intensity set according to the experimental protocol.
A 10-second ramp-up and a 5-second ramp-down period are included in each stimulation condition.
The stimulus waveform is sinusoidal.
Stimulation is delivered using saline-soaked sponge electrodes.
Electrode impedance is maintained below 10 kΩ throughout the stimulation session.
|
|
实验性的：2mA-20Hz HD-tACS
For 2mA-20Hz HD-tACS prevention, we will stimulate the personalized left or right temporal lobe channel at 10 Hz and 0.4mA.
|
The active intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
Stimulation is administered for 90 seconds per condition, with the frequency and current intensity set according to the experimental protocol.
A 10-second ramp-up and a 5-second ramp-down period are included in each stimulation condition.
The stimulus waveform is sinusoidal.
Stimulation is delivered using saline-soaked sponge electrodes.
Electrode impedance is maintained below 10 kΩ throughout the stimulation session.
|
|
实验性的：2mA-40Hz HD-tACS
For 2mA-40Hz HD-tACS prevention, we will stimulate the personalized left or right temporal lobe channel at 10 Hz and 0.4mA.
|
The active intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
Stimulation is administered for 90 seconds per condition, with the frequency and current intensity set according to the experimental protocol.
A 10-second ramp-up and a 5-second ramp-down period are included in each stimulation condition.
The stimulus waveform is sinusoidal.
Stimulation is delivered using saline-soaked sponge electrodes.
Electrode impedance is maintained below 10 kΩ throughout the stimulation session.
|
|
实验性的：2mA-140Hz HD-tACS
For 2mA-140Hz HD-tACS prevention, we will stimulate the personalized left or right temporal lobe channel at 10 Hz and 0.4mA.
|
The active intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
Stimulation is administered for 90 seconds per condition, with the frequency and current intensity set according to the experimental protocol.
A 10-second ramp-up and a 5-second ramp-down period are included in each stimulation condition.
The stimulus waveform is sinusoidal.
Stimulation is delivered using saline-soaked sponge electrodes.
Electrode impedance is maintained below 10 kΩ throughout the stimulation session.
|
|
实验性的：sham HD-tACS
For sham HD-tACS, we will stimulate the personalized left or right temporal lobe channel using sham HD-tACS pattern.
|
The sham intervention consists of high-definition transcranial alternating current stimulation (HD-tACS) delivered using a 4×1 ring configuration (one center electrode surrounded by four return electrodes) over the personalized left or right temporal lobe.
The return electrodes deliver one-quarter of the central electrode current with opposite polarity.
To mimic the sensory experience of active stimulation, the sham condition includes a 10-second ramp-up and a 5-second ramp-down period at 0.4 mA and 140 Hz, with no current delivered during the intervening 90-second period.
|
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 |
|---|---|---|
|
Beta2-band EEG power at the stimulation site
大体时间：180-second recording after each 90-second stimulation
|
Changes in EEG power(dB) in beta2 band within different frequency band measured at the temporal lobe during the 180-second resting-state EEG recording immediately following each stimulation condition.
|
180-second recording after each 90-second stimulation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Alpha-band EEG power at the stimulation site
大体时间：180-second recording after each 90-second stimulation
|
Changes in EEG power(dB) in alpha band within different frequency band measured at the temporal lobe during the 180-second resting-state EEG recording immediately following each stimulation condition.
|
180-second recording after each 90-second stimulation
|
|
Delta-band EEG power at the stimulation site
大体时间：180-second recording after each 90-second stimulation
|
Changes in EEG power(dB) in delta band within different frequency band measured at the temporal lobe during the 180-second resting-state EEG recording immediately following each stimulation condition.
|
180-second recording after each 90-second stimulation
|
|
Theta-band EEG power at the stimulation site
大体时间：180-second recording after each 90-second stimulation
|
Changes in EEG power(dB) in theta band within different frequency band measured at the temporal lobe during the 180-second resting-state EEG recording immediately following each stimulation condition.
|
180-second recording after each 90-second stimulation
|
|
Gamma-band EEG power at the stimulation site
大体时间：180-second recording after each 90-second stimulation
|
Changes in EEG power(dB) in gamma band within different frequency band measured at the temporal lobe during the 180-second resting-state EEG recording immediately following each stimulation condition.
|
180-second recording after each 90-second stimulation
|
|
Beta2-band functional connectivity measured by EEG wPLI
大体时间：180-second recording after each 90-second stimulation
|
Beta2-band functional connectivity between predefined EEG electrodes, quantified using the weighted Phase Lag Index (wPLI), during the 180-second resting-state EEG recording immediately following each stimulation condition.
|
180-second recording after each 90-second stimulation
|
|
Alpha-band functional connectivity measured by EEG wPLI
大体时间：180-second recording after each 90-second stimulation
|
Alpha-band functional connectivity between predefined EEG electrodes, quantified using the weighted Phase Lag Index (wPLI), during the 180-second resting-state EEG recording immediately following each stimulation condition.
|
180-second recording after each 90-second stimulation
|
|
Delta-band functional connectivity measured by EEG wPLI
大体时间：180-second recording after each 90-second stimulation
|
Delta-band functional connectivity between predefined EEG electrodes, quantified using the weighted Phase Lag Index (wPLI), during the 180-second resting-state EEG recording immediately following each stimulation condition.
|
180-second recording after each 90-second stimulation
|
|
Theta-band functional connectivity measured by EEG wPLI
大体时间：180-second recording after each 90-second stimulation
|
Theta-band functional connectivity between predefined EEG electrodes, quantified using the weighted Phase Lag Index (wPLI), during the 180-second resting-state EEG recording immediately following each stimulation condition.
|
180-second recording after each 90-second stimulation
|
|
Gamma-band functional connectivity measured by EEG wPLI
大体时间：180-second recording after each 90-second stimulation
|
Gamma-band functional connectivity between predefined EEG electrodes, quantified using the weighted Phase Lag Index (wPLI), during the 180-second resting-state EEG recording immediately following each stimulation condition.
|
180-second recording after each 90-second stimulation
|
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。
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12月5日
初级完成 (实际的)
2026年2月11日
研究完成 (实际的)
2026年2月15日
研究注册日期
首次提交
2026年7月1日
首先提交符合 QC 标准的
2026年8月29日
首次发布 (实际的)
2026年9月1日
研究记录更新
最后更新发布 (实际的)
2026年9月1日
上次提交的符合 QC 标准的更新
2026年8月29日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他研究编号
- HFJiang-006
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data will not be made publicly available because of privacy and confidentiality considerations related to the collection of electrophysiological data from human participants.
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研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
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.