Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Electro-encephalogram (EEG) Power of Slow Wave Oscillations
研究概览
简要总结
Loss of slow wave sleep (SWS) is common in mild cognitive impairment (MCI) and Alzheimer's disease, and is thought to worsen thinking, memory and brain degeneration. Initial studies suggest that correction of sleep deterioration may slow the progression of brain damage in mild cognitive impairment, and might be able to stop the development of Alzheimer's disease. Transcranial alternating current stimulation (tACS) uses electrodes to deliver very small amounts of electricity through the brain, with direct effects on brain cell function. Transcranial electric stimulation has been demonstrated to enhance slow wave sleep and to improve memory when applied during sleep in healthy adults. The purpose of this research is to investigate tACS to modulate sleep, thinking/memory, mood, and quality of life among normal healthy adults, older adults, as well as individuals with MCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 18-85
- •Native English speakers
- •Neurological diagnosis of amnestic mild cognitive impairment (aMCI)
排除标准
- •brain tumors
- •skull defects
- •metal implants/devices above the neck
- •eczema or sensitive skin
- •sleep apnea that requires use of a CPAP machine
- •rapid eye movement (REM)-sleep behavior disorder
- •currently pregnant or trying to become pregnant during the study period
- •diagnosis of cognitive impairment *cognitive impairment required for MCI arms
研究组 & 干预措施
Effects of tACS during SWS- Standard/Nested 1
This is a triple cross-over with a sham control condition; the standard tACS administered first, then Nested, then sham.
干预措施: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance (Device)
Effects of tACS during SWS- Older Adults Active 1
This is a double cross-over with a sham control condition; the tACS administered first, then the sham
干预措施: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance (Device)
Effects of tACS during SWS- MCI Active 1
This is a cross-over with a sham control condition; the standard tACS administered first, then sham.
干预措施: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance (Device)
Effects of tACS during SWS- Standard/Nested 2
This is a triple cross-over with a sham control condition; the standard tACS administered first, then sham, then nested tACS.
干预措施: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance (Device)
Effects of tACS during SWS- Standard/Nested 3
This is a triple cross-over with a sham control condition; the sham tACS administered first, then nested tACS, then standard tACS.
干预措施: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance (Device)
Effects of tACS during SWS- Older Adults Active 2
This is a double cross-over with a sham control condition; the sham administered first, then the tACS.
干预措施: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance (Device)
Effects of tACS during SWS- MCI Active 2
This is a cross-over with a sham control condition; the sham administered first, then standard tACS.
干预措施: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance (Device)
Effects of tACS during SWS- Standard/Nested 4
This is a triple cross-over with a sham control condition; the sham tACS administered first, then standard tACS, then nested tACS.
干预措施: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance (Device)
Effects of tACS during SWS- Standard/Nested 5
This is a triple cross-over with a sham control condition; the nested tACS administered first, then sham, then standard tACS.
干预措施: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance (Device)
Effects of tACS during SWS- Standard/Nested 6
This is a triple cross-over with a sham control condition; the nested tACS administered first, then standard tACS, then sham.
干预措施: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance (Device)
结局指标
主要结局
Change in Electro-encephalogram (EEG) Power of Slow Wave Oscillations
时间窗: Before and after each night of study session, up to 24 weeks from enrollment for each subject
Power of EEG data in microvolts within slow wave frequency range.
次要结局
- Change in Declarative Memory Encoding(Before and after each night of study session, up to 24 weeks from enrollment for each subject.)
- Change in Procedural Memory Encoding *No Processing of Data Occurred to Provide Information About This Outcome Measure.(Before and after each night of study session, up to 24 weeks from enrollment for each subject)
- Change in Fast and Slow Spindle Numbers During Sleep *No Processing of Data Occurred to Provide Information About This Outcome Measure.(Before and after each night of study session, up to 24 weeks from enrollment for each subject)
- Change in Sleep Architecture as Measured by Minutes in Each Stage of Sleep *No Processing of Data Occurred to Provide Information About This Outcome Measure.(Before and after each night of study session, up to 24 weeks from enrollment for each subject)
- Change in Slow Wave Power *No Processing of Data Occurred to Provide Information About This Outcome Measure.(Before and after each night of study session, up to 24 weeks from enrollment for each subject)
- Change in Slow Wave Coherence *No Processing of Data Occurred to Provide Information About This Outcome Measure.(Before and after each night of study session, up to 24 weeks from enrollment for each subject)
- Change in Sleep Architecture as Measured by Self Reported Sleep Timing *No Processing of Data Occurred to Provide Information About This Outcome Measure.(Before and after each night of study session, up to 24 weeks from enrollment for each subject)
- Change in Hospital Anxiety and Depression Scale (HADS) *No Processing of Data Occurred to Provide Information About This Outcome Measure.(Before and after each night of study session, up to 24 weeks from enrollment for each subject)
- Change in Clinical Global Impression of Change (CGIC) *No Processing of Data Occurred to Provide Information About This Outcome Measure.(Before and after each night of study session, up to 24 weeks from enrollment for each subject)
- Change in Battery of Visuospatial Processing Tasks *No Processing of Data Occurred to Provide Information About This Outcome Measure.(Before and after each night of study session, up to 24 weeks from enrollment for each subject)
- Change in Battery of Working Memory Tasks *No Processing of Data Occurred to Provide Information About This Outcome Measure.(Before and after each night of study session, up to 24 weeks from enrollment for each subject)
- Change in Battery of Attention Tasks *No Processing of Data Occurred to Provide Information About This Outcome Measure.(Before and after each night of study session, up to 24 weeks from enrollment for each subject)