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

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

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.

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.