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

NCT07558616 | Recruiting

• 2 other identifiers: [2025]043-002MR-11-25-042133
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuroimmune Diseases With Insomnia

Outcome Measures

Primary Outcomes (1)

• The change in Pittsburgh Sleep Quality Index (PSQI) scores

  Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to 2 months post-treatment.

  From baseline to 2 months after completion of the 4-week treatment period (up to approximately 12 weeks).

Secondary Outcomes (11)

• The changes in PSQI scores

  From baseline to 1 month after completion of the 4-week treatment period (i.e., up to approximately 8 weeks), with assessments conducted at baseline, at the end of the 4-week treatment (after 20 treatment sessions), and 1 month post-treatment.

• The changes in Insomnia Severity Index (ISI) scores

  From the end of the 4-week treatment period (after 20 treatment sessions) to 2 months post-treatment (up to approximately 12 weeks from baseline), with assessments conducted at the end of treatment, and at 1 and 2 months after treatment.

• The changes in Hamilton Depression Scale (HAMD) scores

  From the end of the 4-week treatment period (after 20 treatment sessions) to 2 months post-treatment (up to approximately 12 weeks from baseline), with assessments conducted at the end of treatment, and at 1 and 2 months after treatment.

• The changes in ini-MentalState Examination scores (MMSE) scores

  From the end of the 4-week treatment period (after 20 treatment sessions) to 2 months post-treatment (up to approximately 12 weeks from baseline), with assessments conducted at the end of treatment, and at 1 and 2 months after treatment.

• The changes in Fatigue Severity Scale (FSS) scores

  From the end of the 4-week treatment period (after 20 treatment sessions) to 2 months post-treatment (up to approximately 12 weeks from baseline), with assessments conducted at the end of treatment, and at 1 and 2 months after treatment.

Other Outcomes (1)

• Adverse Effects Assessment Scale for Transcranial Alternating Current Stimulation (tACS-AE Scale)

  From the first treatment session to the end of the 4-week treatment period (20 sessions; up to approximately 4 weeks), with assessments conducted at each treatment session

Study Arms (2)

Neuromodulation Group

EXPERIMENTAL

Participants receive active transcranial alternating current stimulation (tACS) using the Nexalin ADI device. Electrodes are placed on the forehead (Fp1, Fpz, Fp2 areas of the international 10-20 system; electrode size 4.45 cm × 9.53 cm) and on bilateral mastoids (two electrodes, each 3.18 cm × 3.81 cm). Each session lasts 40 minutes, once daily, for 4 consecutive weeks (5 days intervention + 2 days rest, total 20 sessions). After completing the 20 sessions, there is a 4-week follow-up period without any treatment. At the end of week 4 and at 1 month and 2 months post-treatment, participants are asked about discomfort, abnormal sensations, seizure occurrence, and treatment acceptability.

Device: high-intensity transcranial alternating current stimulation, hi-tACS

Sham Neuromodulation Group

PLACEBO COMPARATOR

Participants receive sham stimulation using a device identical in appearance, buttons, electrodes, odor, and weight to the active device, but no current is delivered. Both participants and investigators are blinded to group assignment. The sham device produces an initial similar sensation to real stimulation to maintain blinding. The treatment schedule (once daily, 40 minutes per session, 20 sessions over 4 weeks) and follow-up assessments are identical to those in the active group.

Device: Sham hi-tACS

Interventions

high-intensity transcranial alternating current stimulation, hi-tACS DEVICE

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.

Neuromodulation Group

Sham hi-tACS DEVICE

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.

Sham Neuromodulation Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

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

Beijing, Beijing Municipality, China

RECRUITING

Study Officials

• Junwei Hao

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yinan Zhao

CONTACT

+86 135 0405 1368; zyn1616@xwhosp.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 30, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 30, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)