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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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

80

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国
        • 募集
        • Department of Neurology, Xuanwu Hospital, Capital Medical University, No. 45 Changchun Street, Beijing, China
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
デバイス：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.
プラセボコンパレーター：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.
デバイス：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
The change in Pittsburgh Sleep Quality Index (PSQI) scores
時間枠：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).

二次結果の測定

結果測定
メジャーの説明
時間枠
The changes in PSQI scores
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Adverse Effects Assessment Scale for Transcranial Alternating Current Stimulation (tACS-AE Scale)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Xuanwu Hospital, Beijing

捜査官

  • 主任研究者：Junwei Hao、Department of Neurology, Xuanwu Hospital, Capital Medical University, No. 45 Changchun Street, Beijing, China

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年9月1日

一次修了 (推定)

2027年7月31日

研究の完了 (推定)

2027年7月31日

試験登録日

最初に提出

2026年4月13日

QC基準を満たした最初の提出物

2026年4月26日

最初の投稿 (実際)

2026年4月30日

学習記録の更新

投稿された最後の更新 (実際)

2026年4月30日

QC基準を満たした最後の更新が送信されました

2026年4月26日

最終確認日

2025年4月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • [2025]043-002
  • MR-11-25-042133 (レジストリ識別子：Study on the clinical efficacy of transcranial strong alternating current (hi-tACS) in patients with neuroimmune diseas)

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個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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