RecruitingNot ApplicableNCT07558616

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


Sponsor

Xuanwu Hospital, Beijing

Enrollment

80 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Sham hi-tACS and a medical device called high-intensity transcranial alternating current stimulation, hi-tACS for people with neuroimmune diseases with insomnia. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEhigh-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, once daily for 40 minutes, for 4 consecutive weeks (5 intervention days + 2 rest days per week). After completing 20 consecutive treatments, participants enter a 4-week observation follow-up period without any treatment.

DEVICESham 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.


Locations(1)

Department of Neurology, Xuanwu Hospital, Capital Medical University, No. 45 Changchun Street, Beijing, China

Beijing, Beijing Municipality, China

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NCT07558616