Actively Recruiting
Study on the Clinical Efficacy of Transcranial Strong Alternating Current (Hi-tACS) in Patients With Neuroimmune Diseases With Insomnia
Led by Xuanwu Hospital, Beijing · Updated on 2026-04-30
80
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study on the Clinical Efficacy of Transcranial Strong Alternating Current (Hi-tACS) in Patients With Neuroimmune Diseases With Insomnia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 65 years with idiopathic inflammatory demyelinating disorders (IIDDs) such as NMOSD or MS, diagnosed by established Chinese guidelines, and experiencing insomnia.
- Patients aged 18 to 65 years diagnosed with chronic primary insomnia according to DSM-IV-TR or ICD-10 criteria.
- Experiencing difficulty falling asleep, staying asleep, or early awakening on at least 3 nights per week for more than 3 months.
- Severe daytime dysfunction as indicated by a Pittsburgh Sleep Quality Index item 7 score of 2 or higher.
- No use of hypnotics or insomnia treatment medication for at least 4 months prior to the study.
- Female participants aged 18 to 50 years agreeing to use effective contraception throughout the study.
- Agreement to avoid medication or other non-pharmacological treatments for insomnia during the study.
- Willingness to participate and provide informed consent.
You will not qualify if you...
- History of disease relapse within the past 1 month.
- Changes in medication within the past 1 month or recent receipt of electroconvulsive therapy, transcranial magnetic stimulation, or other neural control therapies.
- Participation in other clinical studies within 1 month before enrollment or currently.
- Presence of cochlear implants, cardiac pacemakers, or intracerebral implanted stimulators.
- Skin problems or allergies at electrode placement sites.
- History of organic brain diseases such as epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infection.
- Pregnant, breastfeeding, or planning pregnancy soon.
- Severe mental disorders or high suicide risk (score ≥3 on Hamilton Depression Scale suicide item).
- Severe or unstable organic diseases.
- Working night shifts.
- Having other sleep disorders.
- Poor compliance affecting treatment or data collection.
- Other investigator-determined reasons making participation inappropriate.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Neurology, Xuanwu Hospital, Capital Medical University, No. 45 Changchun Street, Beijing, China
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
Y
Yinan Zhao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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