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Study on the Clinical Efficacy of Transcranial Strong Alternating Current (Hi-tACS) in Patients With Neuroimmune Diseases With Insomnia

2026年4月26日 更新者：Xuanwu Hospital, Beijing
This study aims to comprehensively evaluate the therapeutic effects of high-intensity transcranial alternating current stimulation (hi-tACS) on insomnia symptoms in patients with idiopathic inflammatory demyelinating disorders (IIDDs) by analyzing both the overall disease characteristics of IIDDs and individual patient variability. Additionally, the study will investigate the neuroimmunomodulatory mechanisms of hi-tACS. The findings are expected to provide evidence for the clinical application of hi-tACS in managing insomnia in IIDDs and offer new insights for personalized treatment strategies.

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)

80

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

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国
        • 招聘中
        • Department of Neurology, Xuanwu Hospital, Capital Medical University, No. 45 Changchun Street, Beijing, China
        • 接触：

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

不

描述

Inclusion Criteria:

  1. Patients with idiopathic inflammatory demyelinating disorders (IIDDs) meeting the diagnostic criteria, including neuromyelitis optica spectrum disorders (NMOSD) [based on the Chinese Guidelines for Diagnosis and Treatment of Neuromyelitis Optica Spectrum Disorders (2016 Edition)] and multiple sclerosis (MS) [based on the Chinese Guidelines for Diagnosis and Treatment of Multiple Sclerosis (2023 Edition)], and accompanied by insomnia.

    • Aged between 18 and 65 years, regardless of gender.
    • Experiencing difficulty falling asleep, difficulty maintaining sleep, or early morning awakening on at least 3 nights per week for more than 3 months.
    • Severe daytime functional impairment (Chinese version of the Pittsburgh Sleep Quality Index, item 7 [daytime dysfunction] ≥2).
    • Having not taken hypnotics or insomnia treatment medication for at least 4 months.
    • Female participants aged 18-50 years who agree to use effective contraception throughout the study period.
    • Agreeing to refrain from receiving medication or other non-pharmacological treatments during the study period.
    • Agree to participate and sign the informed consent.

  2. Patients diagnosed with chronic primary insomnia according to 《The Diagnostic and Statistical Manual of Mental Disorders》(Text Revision) (DSM-IV-TR) or 《International Classification of Diseases Tenth Revision》(ICD-10):

    • Aged between 18 and 65 years, regardless of gender.
    • Experiencing difficulty falling asleep, difficulty maintaining sleep, or early morning awakening on at least 3 nights per week for more than 3 months.
    • Severe daytime functional impairment (Chinese version of the Pittsburgh Sleep Quality Index, item 7 [daytime dysfunction] ≥2).
    • Having not taken hypnotics or insomnia treatment medication for at least 4 months.
    • Female aged 18~50 years agreeing to adopt birth control measures during the study period.
    • Agreeing to refrain from receiving medication or other non-pharmacological treatments during the study period.
    • Agree to participate and sign the informed consent.

Exclusion Criteria:

  • History of relapse within the past 1 month.
  • Drug adjustment within the past 1 month, or receipt of modified electroconvulsive therapy, transcranial magnetic stimulation therapy, or other neuralcontroltechnology therapy.
  • Participation in any other clinical studies within 1 month prior to enrollment or currently.
  • Presence of cochlear implant system, cardiac-pacemaker, or intracerebral implanted stimulators.
  • Impaired skin integrity at the electrode placement site, or allergy to electrode gel or adhesive.
  • History of organic brain diseases such as epilepsy, hydrocephalus, tumor of central nervous system, craniocerebral injury, or intracranial infection.
  • Pregnant or lactating women, or those intending pregnancy soon;
  • A score of ≥3 on the suicide item of the Hamilton Depression Scale, or coexisting severe mental disorders;
  • Presence of severe or unstable organic diseases;
  • Work night shifts;
  • Presence of other sleep disorders;
  • Poor patient compliance preventing cooperation with treatment, follow-up, or clinical, electroencephalographic (EEG), or imaging data collection;
  • Other circumstances deemed by the investigator as inappropriate for study participation.

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：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Neuromodulation Group
Participants receive active transcranial alternating current stimulation (tACS) using the Nexalin ADI device. Electrodes are placed on the forehead (Fp1, Fpz, Fp2 areas of the international 10-20 system; electrode size 4.45 cm × 9.53 cm) and on bilateral mastoids (two electrodes, each 3.18 cm × 3.81 cm). Each session lasts 40 minutes, once daily, for 4 consecutive weeks (5 days intervention + 2 days rest, total 20 sessions). After completing the 20 sessions, there is a 4-week follow-up period without any treatment. At the end of week 4 and at 1 month and 2 months post-treatment, participants are asked about discomfort, abnormal sensations, seizure occurrence, and treatment acceptability.
设备：high-intensity transcranial alternating current stimulation, hi-tACS
Operations are performed by trained and qualified researchers using the Nexalin ADI device. For both real and sham treatments, 1 electrode (4.45 cm × 9.53 cm) is placed on the prefrontal lobe (corresponding to the Fp1, Fpz, and Fp2 regions of the International 10-20 system scalp EEG recording electrodes), and 2 electrodes (3.18 cm × 3.81 cm each) are placed on the bilateral mastoids (one on each side). Each participant receives 20 sessions of tACS intervention under the same guiding instructions, once daily for 40 minutes, for 4 consecutive weeks (5 intervention days + 2 rest days per week). After completing 20 consecutive treatments, participants enter a 4-week observation follow-up period without any treatment.
安慰剂比较：Sham Neuromodulation Group
Participants receive sham stimulation using a device identical in appearance, buttons, electrodes, odor, and weight to the active device, but no current is delivered. Both participants and investigators are blinded to group assignment. The sham device produces an initial similar sensation to real stimulation to maintain blinding. The treatment schedule (once daily, 40 minutes per session, 20 sessions over 4 weeks) and follow-up assessments are identical to those in the active group.
设备：Sham hi-tACS
The sham treatment device is identical to the real device in all aspects (appearance, buttons, electrodes, odor, weight, etc.) except that it does not emit electrical current. Neither participants nor researchers can distinguish between the real and sham devices by appearance. This design creates an initial sensory experience similar to actual stimulation while maintaining the double-blind nature of the study.

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
The change in Pittsburgh Sleep Quality Index (PSQI) scores
大体时间：From baseline to 2 months after completion of the 4-week treatment period (up to approximately 12 weeks).
Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to 2 months post-treatment.
From baseline to 2 months after completion of the 4-week treatment period (up to approximately 12 weeks).

次要结果测量

结果测量
措施说明
大体时间
The changes in PSQI scores
大体时间：From baseline to 1 month after completion of the 4-week treatment period (i.e., up to approximately 8 weeks), with assessments conducted at baseline, at the end of the 4-week treatment (after 20 treatment sessions), and 1 month post-treatment.
Changes in PSQI scores at baseline, at the end of the 4-week treatment, and 1 month after treatment
From baseline to 1 month after completion of the 4-week treatment period (i.e., up to approximately 8 weeks), with assessments conducted at baseline, at the end of the 4-week treatment (after 20 treatment sessions), and 1 month post-treatment.
The changes in Insomnia Severity Index (ISI) scores
大体时间：From the end of the 4-week treatment period (after 20 treatment sessions) to 2 months post-treatment (up to approximately 12 weeks from baseline), with assessments conducted at the end of treatment, and at 1 and 2 months after treatment.
Changes in Insomnia Severity Index (ISI) scores at the end of the 4-week treatment, and at 1 and 2 months after treatment.
From the end of the 4-week treatment period (after 20 treatment sessions) to 2 months post-treatment (up to approximately 12 weeks from baseline), with assessments conducted at the end of treatment, and at 1 and 2 months after treatment.
The changes in Hamilton Depression Scale (HAMD) scores
大体时间：From the end of the 4-week treatment period (after 20 treatment sessions) to 2 months post-treatment (up to approximately 12 weeks from baseline), with assessments conducted at the end of treatment, and at 1 and 2 months after treatment.
Changes in Hamilton Depression Scale (HAMD) scores at the end of the 4-week treatment, and at 1 and 2 months after treatment.
From the end of the 4-week treatment period (after 20 treatment sessions) to 2 months post-treatment (up to approximately 12 weeks from baseline), with assessments conducted at the end of treatment, and at 1 and 2 months after treatment.
The changes in ini-MentalState Examination scores (MMSE) scores
大体时间：From the end of the 4-week treatment period (after 20 treatment sessions) to 2 months post-treatment (up to approximately 12 weeks from baseline), with assessments conducted at the end of treatment, and at 1 and 2 months after treatment.
Changes in Mini-Mental State Examination (MMSE) scores at the end of the 4-week treatment and at 1 and 2 months after treatment.
From the end of the 4-week treatment period (after 20 treatment sessions) to 2 months post-treatment (up to approximately 12 weeks from baseline), with assessments conducted at the end of treatment, and at 1 and 2 months after treatment.
The changes in Fatigue Severity Scale (FSS) scores
大体时间：From the end of the 4-week treatment period (after 20 treatment sessions) to 2 months post-treatment (up to approximately 12 weeks from baseline), with assessments conducted at the end of treatment, and at 1 and 2 months after treatment.
Changes in Fatigue Severity Scale (FSS) scores at the end of the 4-week treatment and at 1 and 2 months post-treatment
From the end of the 4-week treatment period (after 20 treatment sessions) to 2 months post-treatment (up to approximately 12 weeks from baseline), with assessments conducted at the end of treatment, and at 1 and 2 months after treatment.
The changes in Epworth Sleeping Scale (ESS) scores
大体时间：From the end of the 4-week treatment period (after 20 treatment sessions) to 2 months post-treatment (up to approximately 12 weeks from baseline), with assessments conducted at the end of treatment, and at 1 and 2 months after treatment.
Changes in Epworth Sleeping Scale (ESS) scores at the end of the 4-week treatment and at 1 and 2 months after treatment.
From the end of the 4-week treatment period (after 20 treatment sessions) to 2 months post-treatment (up to approximately 12 weeks from baseline), with assessments conducted at the end of treatment, and at 1 and 2 months after treatment.
The changes in ShortForm-36 Health Survey (SF-36) scores
大体时间：From the end of the 4-week treatment period (after 20 treatment sessions) to 2 months post-treatment (up to approximately 12 weeks from baseline), with assessments conducted at the end of treatment, and at 1 and 2 months after treatment.
Changes in ShortForm-36 Health Survey (SF-36) scores at the end of the 4-week treatment and at 1 and 2 months post-treatment.
From the end of the 4-week treatment period (after 20 treatment sessions) to 2 months post-treatment (up to approximately 12 weeks from baseline), with assessments conducted at the end of treatment, and at 1 and 2 months after treatment.
Changes in accuracy rates and reaction times of emotional face recognition tasks, along with variations in power spectrum, entropy, and coherence metrics
大体时间：From baseline to 2 months after completion of the 20-session treatment period (up to approximately 12 weeks), with assessments conducted at baseline, immediately before and after the 20 treatment sessions, and at 1- and 2-month post-treatment follow-ups.
Changes in accuracy and reaction time in the emotional face recognition task, as well as in power spectrum, entropy, and coherence metrics, from baseline to post-treatment and follow-up assessments.
From baseline to 2 months after completion of the 20-session treatment period (up to approximately 12 weeks), with assessments conducted at baseline, immediately before and after the 20 treatment sessions, and at 1- and 2-month post-treatment follow-ups.
The changes in lymphatic tissues
大体时间：From baseline to 2 months after completion of the 4-week treatment period (up to approximately 12 weeks), with assessments conducted at the end of treatment (after 20 treatment sessions), and at 1 and 2 months post-treatment
Radiological evaluation of lymphatic tissues includes: observation of changes in lymph nodes, lymphoid tissues, and drainage vessels at the end of the 4-week treatment, and at 1 and 2 months after treatment.
From baseline to 2 months after completion of the 4-week treatment period (up to approximately 12 weeks), with assessments conducted at the end of treatment (after 20 treatment sessions), and at 1 and 2 months post-treatment
Alterations in Brain Networks
大体时间：From baseline to 2 months after completion of the 4-week treatment period (up to approximately 12 weeks), with assessments conducted at baseline, at the end of treatment (after 20 treatment sessions), and at 1 and 2 months post-treatment
Alterations in Brain Networks: Monitoring via MRI and Polysomnography (PSG) at the end of the 4-week treatment(at the end of 20 treatment sessions), and at 1 and 2 months after treatment
From baseline to 2 months after completion of the 4-week treatment period (up to approximately 12 weeks), with assessments conducted at baseline, at the end of treatment (after 20 treatment sessions), and at 1 and 2 months post-treatment
The changes in laboratory biomarkers
大体时间：From baseline to 2 months after completion of the 4-week treatment period (up to approximately 12 weeks), with assessments conducted at the end of treatment (after 20 treatment sessions), and at 1 and 2 months post-treatment
Changes in laboratory biomarkers, including IL-6, TNF-α, and IL-1β, were assessed at baseline, at the end of the 4-week treatment (i.e., after completion of 20 treatment sessions), and at 1- and 2-month post-treatment follow-ups.
From baseline to 2 months after completion of the 4-week treatment period (up to approximately 12 weeks), with assessments conducted at the end of treatment (after 20 treatment sessions), and at 1 and 2 months post-treatment

其他结果措施

结果测量
措施说明
大体时间
Adverse Effects Assessment Scale for Transcranial Alternating Current Stimulation (tACS-AE Scale)
大体时间：From the first treatment session to the end of the 4-week treatment period (20 sessions; up to approximately 4 weeks), with assessments conducted at each treatment session
Adverse Effects Assessment Scale for Transcranial Alternating Current Stimulation (tACS-AE Scale)
From the first treatment session to the end of the 4-week treatment period (20 sessions; up to approximately 4 weeks), with assessments conducted at each treatment session

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

Xuanwu Hospital, Beijing

调查人员

  • 首席研究员：Junwei Hao、Department of Neurology, Xuanwu Hospital, Capital Medical University, No. 45 Changchun Street, Beijing, China

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9月1日

初级完成 (估计的)

2027年7月31日

研究完成 (估计的)

2027年7月31日

研究注册日期

首次提交

2026年4月13日

首先提交符合 QC 标准的

2026年4月26日

首次发布 (实际的)

2026年4月30日

研究记录更新

最后更新发布 (实际的)

2026年4月30日

上次提交的符合 QC 标准的更新

2026年4月26日

最后验证

2025年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • [2025]043-002
  • MR-11-25-042133 (注册表标识符：Study on the clinical efficacy of transcranial strong alternating current (hi-tACS) in patients with neuroimmune diseas)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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

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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