Efficacy and Safety of Transcranial Magnetic Stimulation in Treatment of Insomnia with Subjective Cognitive Decline
1 other identifier
interventional
66
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2024
CompletedFirst Posted
Study publicly available on registry
November 29, 2024
CompletedStudy Start
First participant enrolled
January 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
November 29, 2024
November 1, 2024
1.5 years
November 26, 2024
November 26, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (13)
Change from baseline MoCA scores to 2 weeks
Baseline vs 2 weeks after treatment
Change from baseline CDR to 2 weeks
Baseline vs 2 weeks after treatment
Change from baseline RAVLT to 2 weeks
Baseline vs 2 weeks after treatment
Change from baseline HAMA to 2 weeks
Baseline vs 2 weeks after treatment
Change from baseline HAMD to 2 weeks
Baseline vs 2 weeks after treatment
- +8 more secondary outcomes
Study Arms (2)
rTMS
EXPERIMENTALsham rTMS
SHAM COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- (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.
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2024
First Posted
November 29, 2024
Study Start
January 1, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
November 29, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share