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

Обзор

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.

Вмешательства

• Устройство 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
• Устройство 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.

Первичные конечные точки

• The change in Pittsburgh Sleep Quality Index (PSQI) scores [Срок оценки: From baseline to 2 months after completion of the 4-week treatment period (up to approximately 12 weeks).]

Вторичные конечные точки (11)

• The changes in PSQI scores [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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]

Критерии участия

Критерии включения

• 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.
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Department of Neurology, Xuanwu Hospital, Capital Medical University, No. 45 Changchun Str — Пекин

Идентификаторы

NCT: NCT07558616 · [2025]043-002 · MR-11-25-042133

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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