Clinical trial NCT06710652: Efficacy and Safety of Transcranial Magnetic Stimulation in Treatment of Insomnia with Subjective Cognitive Decline
Official title: Efficacy and Safety of Transcranial Magnetic Stimulation in Treatment of Insomnia with Subjective Cognitive Decline: a Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Insomnia Chronic
Subjective Cognitive Decline (SCD)
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 66
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline SCD-Q9 to 2 weeks
timeFrame: Baseline vs 2 weeks after treatment
measure: Change from baseline MMSE to 2 weeks
timeFrame: Baseline vs 2 weeks after treatment
Secondary outcomes:
measure: Change from baseline MoCA scores to 2 weeks
timeFrame: Baseline vs 2 weeks after treatment
measure: Change from baseline CDR to 2 weeks
timeFrame: Baseline vs 2 weeks after treatment
measure: Change from baseline RAVLT to 2 weeks
timeFrame: Baseline vs 2 weeks after treatment
measure: Change from baseline HAMA to 2 weeks
timeFrame: Baseline vs 2 weeks after treatment
measure: Change from baseline HAMD to 2 weeks
timeFrame: Baseline vs 2 weeks after treatment
measure: Change from baseline NPI to 2 weeks
timeFrame: Baseline vs 2 weeks after treatment
measure: Change from baseline CDS to 2 weeks
timeFrame: Baseline vs 2 weeks after treatment
measure: Change from baseline DDS to 2 weeks
timeFrame: Baseline vs 2 weeks after treatment
measure: Change from baseline inflammatory factors and neuropathological markers to 2 weeks
timeFrame: Baseline vs 2 weeks after treatment
measure: Change from baseline PAF to 2 weeks
timeFrame: Baseline vs 2 weeks after treatment
measure: Change from baseline structural imaging indicators to 2 weeks
timeFrame: Baseline vs 2 weeks after treatment
measure: Change from baseline adverse events to 2 weeks
timeFrame: Baseline vs 2 weeks after treatment
measure: Change from baseline TMS-EEG to 2 weeks
timeFrame: Baseline vs 2 weeks after treatment
Other outcomes:
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