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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia Chronic; Subjective Cognitive Decline (SCD)
• Intervention / Treatment: Device: rTMS; Device: Sham Comparator

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaodong Pan; Phone Number: 0591-86218341; Email: panxd@fjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rTMS	Device: rTMS; 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: sham rTMS	Device: Sham 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Cognitive Dysfunction; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: rTMS-insomnia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No