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

Inclusion criteria

• 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.

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.