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| ID | Type | Description | Link |
|---|---|---|---|
| MR-11-25-042133 | Registry Identifier | Study on the clinical efficacy of transcranial strong alternating current (hi-tACS) in patients with neuroimmune diseas |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| The changes in PSQI scores | Changes in PSQI scores at baseline, at the end of the 4-week treatment, and 1 month after treatment | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Effects Assessment Scale for Transcranial Alternating Current Stimulation (tACS-AE Scale) | 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 |
Inclusion Criteria:
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):
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yinan Zhao | Contact | +86 135 0405 1368 | zyn1616@xwhosp.org |
| Name | Affiliation | Role |
|---|---|---|
| Junwei Hao | Department of Neurology, Xuanwu Hospital, Capital Medical University, No. 45 Changchun Street, Beijing, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, Xuanwu Hospital, Capital Medical University, No. 45 Changchun Street, Beijing, China | Recruiting | Beijing | Beijing Municipality | China |
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| 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. |
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| 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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. | 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 | 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. | 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 |