Insomnia Chronic, Subjective Cognitive Decline (SCD)
Conditions
Brief summary
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.
Interventions
DEVICErTMS
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.
DEVICESham Comparator
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.
Sponsors
Fujian Medical University Union Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* (1) Aged 30-80 years old; (2) Diagnostic criteria for insomnia: DSM-V and ICSD-3; (3) Subjective cognitive decline. (4) Regular use of non-benzodiazepines for insomnia.
Exclusion criteria
* (1) Refuse participants; (2) Presence of cognitive dysfunction; (3) Combined with other diseases other than central nervous system non-neurodegenerative diseases; (4) Use drugs that may affect cognition, degree of awakening and sleep quality due to other diseases; (5) Contraindications to rTMS treatment: (6) Severe complications and immune diseases; (7) Inability to cooperate; (8) Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline SCD-Q9 to 2 weeks | Baseline vs 2 weeks after treatment | 9-item Subjective Cognitive Decline Questionnaire (SCD-Q9) |
| Change from baseline MMSE to 2 weeks | Baseline vs 2 weeks after treatment | Mini-Mental State Examination (MMSE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline RAVLT to 2 weeks | Baseline vs 2 weeks after treatment | Rey Auditory Verbal Learning Test (RAVLT) |
| Change from baseline HAMA to 2 weeks | Baseline vs 2 weeks after treatment | Human Anti-Murine Antibodies (HAMA) |
| Change from baseline HAMD to 2 weeks | Baseline vs 2 weeks after treatment | Hamilton Rating Scale for Depression (HAMD) |
| Change from baseline NPI to 2 weeks | Baseline vs 2 weeks after treatment | Neuropsychiatric Inventory (NPI) |
| Change from baseline CDS to 2 weeks | Baseline vs 2 weeks after treatment | Coding Digit Symbol subtest (CDS) |
| Change from baseline MoCA scores to 2 weeks | Baseline vs 2 weeks after treatment | Montreal Cognitive Assessment (MoCA) |
| Change from baseline inflammatory factors and neuropathological markers to 2 weeks | Baseline vs 2 weeks after treatment | 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. |
| Change from baseline PAF to 2 weeks | Baseline vs 2 weeks after treatment | The alpha-peak frequency (PAF) is the frequency with the highest power within the alpha-band. |
| Change from baseline structural imaging indicators to 2 weeks | Baseline vs 2 weeks after treatment | 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). |
| Change from baseline adverse events to 2 weeks | Baseline vs 2 weeks after treatment | Headache, tinnitus, pure tone hearing disorder, ect. |
| Change from baseline TMS-EEG to 2 weeks | Baseline vs 2 weeks after treatment | Concurrent transcranial magnetic stimulation and electroencephalography (TMS-EEG) |
| Change from baseline DDS to 2 weeks | Baseline vs 2 weeks after treatment | Direct Digit Span subtest (DDS) |
| Change from baseline CDR to 2 weeks | Baseline vs 2 weeks after treatment | Clinical Dementia Rating (CDR) |
Contacts
Primary ContactXiaodong Pan
Outcome results
None listed