Efficacy and Safety of Transcranial Magnetic Stimulation in Treatment of Insomnia with Subjective Cognitive Decline: a Randomized Controlled Trail
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 主要终点
- Change from baseline SCD-Q9 to 2 weeks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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.
排除标准
- •(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.
研究组 & 干预措施
rTMS
干预措施: rTMS (Device)
sham rTMS
干预措施: Sham Comparator (Device)
结局指标
主要结局
Change from baseline SCD-Q9 to 2 weeks
时间窗: Baseline vs 2 weeks after treatment
9-item Subjective Cognitive Decline Questionnaire (SCD-Q9)
Change from baseline MMSE to 2 weeks
时间窗: Baseline vs 2 weeks after treatment
Mini-Mental State Examination (MMSE)
次要结局
- Change from baseline CDR to 2 weeks(Baseline vs 2 weeks after treatment)
- Change from baseline MoCA scores 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)