High-intensity alternating current therapy (hi-tACS) for insomnia in neuroimmune disorders

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

This test sees if high-intensity transcranial alternating current stimulation (hi‑tACS) can reduce chronic insomnia in adults with neuroimmune disorders such as multiple sclerosis or neuromyelitis optica spectrum disorder.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07558616 on ClinicalTrials.gov

What this trial studies

The trial enrolls adults aged 18–65 with idiopathic inflammatory demyelinating disorders (including MS and NMOSD) who have chronic insomnia and daytime dysfunction. Participants will receive either high‑intensity hi‑tACS or a sham hi‑tACS procedure, with sleep symptoms and daytime function tracked during and after the intervention. The protocol includes analysis of overall disease characteristics and individual variability in treatment response. Investigators will also measure neuroimmune markers to explore possible mechanisms linking brain stimulation to sleep improvements and to support personalized approaches.

Who should consider this trial

Good fit: Adults 18–65 with a confirmed idiopathic inflammatory demyelinating disorder (MS or NMOSD) who have chronic insomnia (≥3 nights/week for >3 months), significant daytime dysfunction (PSQI item 7 ≥2), have not used hypnotics for at least 4 months, and (if female aged 18–50) agree to effective contraception.

Not a fit: People without IIDDs, those under 18 or over 65, individuals currently using hypnotic medications, those with untreated comorbid sleep disorders (such as severe sleep apnea), or those in an acute neurologic relapse are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, hi‑tACS could provide a non‑drug option that reduces insomnia symptoms and improves daytime function for people with MS or NMOSD.

How similar studies have performed: Noninvasive brain stimulation methods (tACS/tDCS) have produced mixed but sometimes promising sleep benefits in prior studies, while high‑intensity hi‑tACS specifically in neuroimmune patients remains relatively novel and less tested.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Department of Neurology, Xuanwu Hospital, Capital Medical University, No. 45 Changchun Street, Beijing, China — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Junwei Hao — Department of Neurology, Xuanwu Hospital, Capital Medical University, No. 45 Changchun Street, Beijing, China
• Study coordinator: Yinan Zhao

Conditions Neuroimmune Diseases With Insomnia