Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance
- Conditions
- Mild Cognitive Impairment
- Interventions
- Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance
- Registration Number
- NCT03112902
- Lead Sponsor
- University of Colorado, Denver
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 24
- Ages 18-85
- Native English speakers
- Neurological diagnosis of amnestic mild cognitive impairment (aMCI)
- brain tumors
- skull defects
- epilepsy
- metal implants/devices above the neck
- eczema or sensitive skin
- insomnia
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Effects of tACS during SWS- Standard/Nested 1 Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance This is a triple cross-over with a sham control condition; the standard tACS administered first, then Nested, then sham. Effects of tACS during SWS- Older Adults Active 1 Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance This is a double cross-over with a sham control condition; the tACS administered first, then the sham Effects of tACS during SWS- MCI Active 1 Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance This is a cross-over with a sham control condition; the standard tACS administered first, then sham. Effects of tACS during SWS- Standard/Nested 3 Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance This is a triple cross-over with a sham control condition; the sham tACS administered first, then nested tACS, then standard tACS. Effects of tACS during SWS- Standard/Nested 2 Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance This is a triple cross-over with a sham control condition; the standard tACS administered first, then sham, then nested tACS. Effects of tACS during SWS- Standard/Nested 6 Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance This is a triple cross-over with a sham control condition; the nested tACS administered first, then standard tACS, then sham. Effects of tACS during SWS- MCI Active 2 Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance This is a cross-over with a sham control condition; the sham administered first, then standard tACS. Effects of tACS during SWS- Standard/Nested 5 Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance This is a triple cross-over with a sham control condition; the nested tACS administered first, then sham, then standard tACS. Effects of tACS during SWS- Older Adults Active 2 Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance This is a double cross-over with a sham control condition; the sham administered first, then the tACS. Effects of tACS during SWS- Standard/Nested 4 Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance This is a triple cross-over with a sham control condition; the sham tACS administered first, then standard tACS, then nested tACS.
- Primary Outcome Measures
Name Time Method Change in Electro-encephalogram (EEG) Power of Slow Wave Oscillations 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.
- Secondary Outcome Measures
Name Time Method Change in Declarative Memory Encoding Before and after each night of study session, up to 24 weeks from enrollment for each subject. Word-paired associations
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 Finger tapping task \*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure
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 EEG data \*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure
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 EEG data \*No processing of data occurred to provide information about this outcome measure.
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 EEG data \*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure
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 EEG data \*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure
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 Sleep diary for subjective experience \*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure
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 Mood outcome \*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure
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 Global assessment \*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure
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 Assessment of visuospatial ability \*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure
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 Assessment of working memory \*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure
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 Assessment of attention \*Problems and new insights related to the study's design were encountered during data collection that fundamentally affected the rationale and feasibility of the trial. Trial was terminated before sufficient data could be collected and analyzed. No data was analyzed for this outcome measure
Trial Locations
- Locations (1)
University of Colorado AMC
🇺🇸Aurora, Colorado, United States