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NCT Number: NCT06710652

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

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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Key information

Conditions

Insomnia Chronic Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Subjective Cognitive Decline (SCD)

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change from baseline SCD-Q9 to 2 weeks

    Time frame: Baseline vs 2 weeks after treatment

    9-item Subjective Cognitive Decline Questionnaire (SCD-Q9)

  2. Change from baseline MMSE to 2 weeks

    Time frame: Baseline vs 2 weeks after treatment

    Mini-Mental State Examination (MMSE)

Secondary outcomes

  1. Change from baseline MoCA scores to 2 weeks

    Time frame: Baseline vs 2 weeks after treatment

    Montreal Cognitive Assessment (MoCA)

  2. Change from baseline CDR to 2 weeks

    Time frame: Baseline vs 2 weeks after treatment

    Clinical Dementia Rating (CDR)

  3. Change from baseline RAVLT to 2 weeks

    Time frame: Baseline vs 2 weeks after treatment

    Rey Auditory Verbal Learning Test (RAVLT)

  4. Change from baseline HAMA to 2 weeks

    Time frame: Baseline vs 2 weeks after treatment

    Human Anti-Murine Antibodies (HAMA)

  5. Change from baseline HAMD to 2 weeks

    Time frame: Baseline vs 2 weeks after treatment

    Hamilton Rating Scale for Depression (HAMD)

  6. Change from baseline NPI to 2 weeks

    Time frame: Baseline vs 2 weeks after treatment

    Neuropsychiatric Inventory (NPI)

  7. Change from baseline CDS to 2 weeks

    Time frame: Baseline vs 2 weeks after treatment

    Coding Digit Symbol subtest (CDS)

  8. Change from baseline DDS to 2 weeks

    Time frame: Baseline vs 2 weeks after treatment

    Direct Digit Span subtest (DDS)

  9. Change from baseline inflammatory factors and neuropathological markers to 2 weeks

    Time frame: 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.

  10. Change from baseline PAF to 2 weeks

    Time frame: Baseline vs 2 weeks after treatment

    The alpha-peak frequency (PAF) is the frequency with the highest power within the alpha-band.

  11. Change from baseline structural imaging indicators to 2 weeks

    Time frame: 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).

  12. Change from baseline adverse events to 2 weeks

    Time frame: Baseline vs 2 weeks after treatment

    Headache, tinnitus, pure tone hearing disorder, ect.

  13. Change from baseline TMS-EEG to 2 weeks

    Time frame: Baseline vs 2 weeks after treatment

    Concurrent transcranial magnetic stimulation and electroencephalography (TMS-EEG)

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaodong Pan

CONTACT

[email protected]

0591-86218341

Sponsors and collaborators

Lead sponsor

Fujian Medical University Union Hospital

Other

Registry information

Official study title

Efficacy and Safety of Transcranial Magnetic Stimulation in Treatment of Insomnia with Subjective Cognitive Decline: a Randomized Controlled Trail

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 29, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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