Efficacy and Safety of Transcranial Magnetic Stimulation in Treatment of Insomnia with Subjective Cognitive Decline: a Randomized Controlled Trail
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Insomnia Chronic
- Sponsor
- Fujian Medical University Union Hospital
- Enrollment
- 66
- Primary Endpoint
- Change from baseline SCD-Q9 to 2 weeks
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Change from baseline SCD-Q9 to 2 weeks
Time Frame: Baseline vs 2 weeks after treatment
9-item Subjective Cognitive Decline Questionnaire (SCD-Q9)
Change from baseline MMSE to 2 weeks
Time Frame: Baseline vs 2 weeks after treatment
Mini-Mental State Examination (MMSE)
Secondary Outcomes
- 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)
- Change from baseline NPI to 2 weeks(Baseline vs 2 weeks after treatment)
- Change from baseline CDS to 2 weeks(Baseline vs 2 weeks after treatment)
- Change from baseline DDS to 2 weeks(Baseline vs 2 weeks after treatment)
- Change from baseline inflammatory factors and neuropathological markers to 2 weeks(Baseline vs 2 weeks after treatment)
- Change from baseline PAF to 2 weeks(Baseline vs 2 weeks after treatment)
- Change from baseline structural imaging indicators to 2 weeks(Baseline vs 2 weeks after treatment)
- Change from baseline adverse events to 2 weeks(Baseline vs 2 weeks after treatment)
- Change from baseline TMS-EEG to 2 weeks(Baseline vs 2 weeks after treatment)