Neuroimmune Diseases With InsomniaNCT07558616

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

A study testing high-intensity transcranial alternating current stimulation, hi-tACS in people with Neuroimmune Diseases With Insomnia, run by Xuanwu Hospital, Beijing at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Neuroimmune Diseases With Insomnia
What is being tested?: high-intensity transcranial alternating current stimulation, hi-tACS
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteChina
Study dates: 1 Sep 2025to 31 Jul 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yinan Zhao contact

+86 135 0405 1368

zyn1616@xwhosp.org

China1 site, 1 recruiting

Department of Neurology, Xuanwu Hospital, Capital Medical University, No. 45 Changchun Street, Beijing, China
Beijing, Beijing Municipality
Yinan Zhao, +86 135 0405 1368, zyn1616@xwhosp.org
Recruiting

Other trials in China

About this study

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
Being tested: high-intensity transcranial alternating current stimulation, hi-tACS, Sham hi-tACS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

high-intensity transcranial alternating current stimulation, hi-tACSDevice
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.
Sham hi-tACSDevice
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.

Study groups in NCT07558616
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Sham hi-tACS

What is being measured

The primary outcome is the main question the study is designed to answer.

The change in Pittsburgh Sleep Quality Index (PSQI) scores
Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to 2 months post-treatment.
Measured: 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
Changes in PSQI scores at baseline, at the end of the 4-week treatment, and 1 month after treatment
Measured: 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
Changes in Insomnia Severity Index (ISI) scores at the end of the 4-week treatment, and at 1 and 2 months after treatment.
Measured: 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
Changes in Hamilton Depression Scale (HAMD) scores at the end of the 4-week treatment, and at 1 and 2 months after treatment.
Measured: 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
Changes in Mini-Mental State Examination (MMSE) scores at the end of the 4-week treatment and at 1 and 2 months after treatment.
Measured: 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
Changes in Fatigue Severity Scale (FSS) scores at the end of the 4-week treatment and at 1 and 2 months post-treatment
Measured: 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 Epworth Sleeping Scale (ESS) scores
Changes in Epworth Sleeping Scale (ESS) scores at the end of the 4-week treatment and at 1 and 2 months after treatment.
Measured: 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 ShortForm-36 Health Survey (SF-36) scores
Changes in ShortForm-36 Health Survey (SF-36) scores at the end of the 4-week treatment and at 1 and 2 months post-treatment.
Measured: 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.
Changes in accuracy rates and reaction times of emotional face recognition tasks, along with variations in power spectrum, entropy, and coherence metrics
Changes in accuracy and reaction time in the emotional face recognition task, as well as in power spectrum, entropy, and coherence metrics, from baseline to post-treatment and follow-up assessments.
Measured: From baseline to 2 months after completion of the 20-session treatment period (up to approximately 12 weeks), with assessments conducted at baseline, immediately before and after the 20 treatment sessions, and at 1- and 2-month post-treatment follow-ups.
The changes in lymphatic tissues
Radiological evaluation of lymphatic tissues includes: observation of changes in lymph nodes, lymphoid tissues, and drainage vessels at the end of the 4-week treatment, and at 1 and 2 months after treatment.
Measured: From baseline to 2 months after completion of the 4-week treatment period (up to approximately 12 weeks), with assessments conducted at the end of treatment (after 20 treatment sessions), and at 1 and 2 months post-treatment
Alterations in Brain Networks
Alterations in Brain Networks: Monitoring via MRI and Polysomnography (PSG) at the end of the 4-week treatment(at the end of 20 treatment sessions), and at 1 and 2 months after treatment
Measured: From baseline to 2 months after completion of the 4-week treatment period (up to approximately 12 weeks), with assessments conducted at baseline, at the end of treatment (after 20 treatment sessions), and at 1 and 2 months post-treatment
The changes in laboratory biomarkers
Changes in laboratory biomarkers, including IL-6, TNF-α, and IL-1β, were assessed at baseline, at the end of the 4-week treatment (i.e., after completion of 20 treatment sessions), and at 1- and 2-month post-treatment follow-ups.
Measured: From baseline to 2 months after completion of the 4-week treatment period (up to approximately 12 weeks), with assessments conducted at the end of treatment (after 20 treatment sessions), and at 1 and 2 months post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202531 Jul 2027

First posted30 Apr 2026
Study start1 Sep 2025
Primary completion31 Jul 2027 (estimated)
Study completion31 Jul 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Neuroimmune Diseases With InsomniaStudies of the same condition, open and under way.
More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07558616
Sponsor's protocol ID: [2025]043-002
Other IDs: MR-11-25-042133
Status last verified: Apr 2025
First submitted: 13 Apr 2026
Last updated: 30 Apr 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study on the Clinical Efficacy of Transcranial Strong Alternating Current (Hi-tACS) in Patients With Neuroimmune Diseases With Insomnia
ClinicalTrials.gov ID: NCT07558616
Acronym / sponsor ID: [2025]043-002
Conditions: Neuroimmune Diseases With Insomnia
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 80 participants (estimated)
Lead sponsor: Xuanwu Hospital, BeijingUniversity, hospital or other
Study start: 1 Sep 2025 (actual)
Primary completion: 31 Jul 2027 (estimated)
Study completion: 31 Jul 2027 (estimated)
First posted: 30 Apr 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Neuromodulation Group	Experimental	Device: high-intensity transcranial alternating current stimulation, hi-tACSParticipants 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.
Sham Neuromodulation Group	Placebo comparator	Device: Sham hi-tACSParticipants 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

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.
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):

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
high-intensity transcranial alternating current stimulation, hi-tACSOperations 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.	Device	Neuromodulation Group
Sham hi-tACSThe 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.	Device	Sham Neuromodulation Group

Primary outcome

The change in Pittsburgh Sleep Quality Index (PSQI) scores
Time frame: From baseline to 2 months after completion of the 4-week treatment period (up to approximately 12 weeks).
Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to 2 months post-treatment.

11 secondary outcomes

The changes in PSQI scores
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 Epworth Sleeping Scale (ESS) scores
Time frame: 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 ShortForm-36 Health Survey (SF-36) scores
Time frame: 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.
Changes in accuracy rates and reaction times of emotional face recognition tasks, along with variations in power spectrum, entropy, and coherence metrics
Time frame: From baseline to 2 months after completion of the 20-session treatment period (up to approximately 12 weeks), with assessments conducted at baseline, immediately before and after the 20 treatment sessions, and at 1- and 2-month post-treatment follow-ups.
The changes in lymphatic tissues
Time frame: From baseline to 2 months after completion of the 4-week treatment period (up to approximately 12 weeks), with assessments conducted at the end of treatment (after 20 treatment sessions), and at 1 and 2 months post-treatment
Alterations in Brain Networks
Time frame: From baseline to 2 months after completion of the 4-week treatment period (up to approximately 12 weeks), with assessments conducted at baseline, at the end of treatment (after 20 treatment sessions), and at 1 and 2 months post-treatment
The changes in laboratory biomarkers
Time frame: From baseline to 2 months after completion of the 4-week treatment period (up to approximately 12 weeks), with assessments conducted at the end of treatment (after 20 treatment sessions), and at 1 and 2 months post-treatment

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Yinan Zhao contact

+86 135 0405 1368

zyn1616@xwhosp.org

Junwei Hao principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing high-intensity transcranial alternating current stimulation, hi-tACS in people with Neuroimmune Diseases With Insomnia, run by Xuanwu Hospital, Beijing at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yinan Zhao (+86 135 0405 1368, zyn1616@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change in Pittsburgh Sleep Quality Index (PSQI) scores (time frame: From baseline to 2 months after completion of the 4-week treatment period (up to approximately 12 weeks).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07558616.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.