Efficacy and Safety of Transcranial Magnetic Stimulation in Treatment of Insomnia with Subjective Cognitive Decline

Not Applicable

Not yet recruiting

• Conditions: Insomnia Chronic; Subjective Cognitive Decline (SCD)

• Registration Number: NCT06710652
• Lead Sponsor: Fujian Medical University Union Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-28
• Last Update Posted: 2024-11-28
• Study Start: 2025-01-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change from baseline MoCA scores to 2 weeks	Baseline vs 2 weeks after treatment	Montreal Cognitive Assessment (MoCA)
Change from baseline CDR to 2 weeks	Baseline vs 2 weeks after treatment	Clinical Dementia Rating (CDR)
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 DDS to 2 weeks	Baseline vs 2 weeks after treatment	Direct Digit Span subtest (DDS)
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)