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Insomnia is the most common form of sleep disorder, and subjective cognitive decline (SCD) in patients with insomnia may be an ultra-early manifestation of AD. Repetitive transcranial magnetic stimulation (rTMS) has emerged as a promising tool for the treatment of insomnia by modulating neural excitability and inducing plasticity. However, there is a lack of studies on rTMS treatment of cognitive impairment associated with insomnia. The efficacy and safety of rTMS for cognitive impairment in insomnia patients with SCD will be assessed by a randomized controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rTMS | Experimental |
| |
| sham rTMS | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS | Device | Stimulation coil Cool-B65 A CO, located right lingual gyrus, stimulation frequency 1Hz, stimulation intensity 80% of motor threshold, number of stimuli 3 pulses/train, train interval 1s, 500 trains in total, 1500 total stimulation pulses, total stimulation time 20 min, treatment application once a day, continuous application for two weeks, 5 days a week. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline SCD-Q9 to 2 weeks | 9-item Subjective Cognitive Decline Questionnaire (SCD-Q9) | Baseline vs 2 weeks after treatment |
| Change from baseline MMSE to 2 weeks | Mini-Mental State Examination (MMSE) | Baseline vs 2 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline MoCA scores to 2 weeks | Montreal Cognitive Assessment (MoCA) | Baseline vs 2 weeks after treatment |
| Change from baseline CDR to 2 weeks | Clinical Dementia Rating (CDR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaodong Pan | Contact | 0591-86218341 | panxd@fjmu.edu.cn |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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|
| Sham Comparator | Device | Stimulation coil Cool-B65 P CO, located right lingual gyrus, stimulation frequency 1Hz, stimulation intensity 80% of motor threshold, number of stimuli 3 pulses/train, train interval 1s, 500 trains in total, 1500 total stimulation pulses, total stimulation time 20 min, treatment application once a day, continuous application for two weeks, 5 days a week. |
|
| Baseline vs 2 weeks after treatment |
| Change from baseline RAVLT to 2 weeks | Rey Auditory Verbal Learning Test (RAVLT) | Baseline vs 2 weeks after treatment |
| Change from baseline HAMA to 2 weeks | Human Anti-Murine Antibodies (HAMA) | Baseline vs 2 weeks after treatment |
| Change from baseline HAMD to 2 weeks | Hamilton Rating Scale for Depression (HAMD) | Baseline vs 2 weeks after treatment |
| Change from baseline NPI to 2 weeks | Neuropsychiatric Inventory (NPI) | Baseline vs 2 weeks after treatment |
| Change from baseline CDS to 2 weeks | Coding Digit Symbol subtest (CDS) | Baseline vs 2 weeks after treatment |
| Change from baseline DDS to 2 weeks | Direct Digit Span subtest (DDS) | Baseline vs 2 weeks after treatment |
| Change from baseline inflammatory factors and neuropathological markers to 2 weeks | Aβ, tau, GFAP, α-Synuclein, NFL, VEGF, AQP4, RNA sequencing, pre.Caspase1, cl.Caspase1, pre.IL-1β, cl.IL-1β, IL-18, GSDMD, ASC, NLRP1, Iba-1, GFAP, NeuN, CD86, CD206, iNOS, Arg1, TLR4, TLR2, MyD88, NFκB, tau, p-NFκB, NLRP3, β-actin, ect. | Baseline vs 2 weeks after treatment |
| Change from baseline PAF to 2 weeks | The alpha-peak frequency (PAF) is the frequency with the highest power within the alpha-band. | Baseline vs 2 weeks after treatment |
| Change from baseline structural imaging indicators to 2 weeks | The intra-cellular compartment (Vic) of the Neurite Orientation Dispersion and Density Imaging (NODDI) model represents diffusion within the axons and cells.And NODDI models the dispersion of axonal fibers with the use of an Orientation Dispersion Index (ODI). | Baseline vs 2 weeks after treatment |
| Change from baseline adverse events to 2 weeks | Headache, tinnitus, pure tone hearing disorder, ect. | Baseline vs 2 weeks after treatment |
| Change from baseline TMS-EEG to 2 weeks | Concurrent transcranial magnetic stimulation and electroencephalography (TMS-EEG) | Baseline vs 2 weeks after treatment |
| D001523 |
| Mental Disorders |