Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance

Study Overview
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Brief Summary
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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.

Official Title
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Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18-85 Native English speakers Neurological diagnosis of amnestic mild cognitive impairment (aMCI) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Effects of tACS during SWS- Standard/Nested 1<br>This is a triple cross-over with a sham control condition; the standard tACS administered first, then Nested, then sham. | Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance<br>* Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.<br>|
| Active Comparator: Effects of tACS during SWS- Older Adults Active 1<br>This is a double cross-over with a sham control condition; the tACS administered first, then the sham | Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance<br>* Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.<br>|
| Active Comparator: Effects of tACS during SWS- MCI Active 1<br>This is a cross-over with a sham control condition; the standard tACS administered first, then sham. | Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance<br>* Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.<br>|
| Active Comparator: Effects of tACS during SWS- Standard/Nested 2<br>This is a triple cross-over with a sham control condition; the standard tACS administered first, then sham, then nested tACS. | Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance<br>* Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.<br>|
| Active Comparator: Effects of tACS during SWS- Standard/Nested 3<br>This is a triple cross-over with a sham control condition; the sham tACS administered first, then nested tACS, then standard tACS. | Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance<br>* Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.<br>|
| Active Comparator: Effects of tACS during SWS- Older Adults Active 2<br>This is a double cross-over with a sham control condition; the sham administered first, then the tACS. | Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance<br>* Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.<br>|
| Active Comparator: Effects of tACS during SWS- MCI Active 2<br>This is a cross-over with a sham control condition; the sham administered first, then standard tACS. | Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance<br>* Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.<br>|
| Active Comparator: Effects of tACS during SWS- Standard/Nested 4<br>This is a triple cross-over with a sham control condition; the sham tACS administered first, then standard tACS, then nested tACS. | Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance<br>* Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.<br>|
| Active Comparator: Effects of tACS during SWS- Standard/Nested 5<br>This is a triple cross-over with a sham control condition; the nested tACS administered first, then sham, then standard tACS. | Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance<br>* Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.<br>|
| Active Comparator: Effects of tACS during SWS- Standard/Nested 6<br>This is a triple cross-over with a sham control condition; the nested tACS administered first, then standard tACS, then sham. | Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance<br>* Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Electro-encephalogram (EEG) Power of Slow Wave Oscillations | Power of EEG data in microvolts within slow wave frequency range. | Before and after each night of study session, up to 24 weeks from enrollment for each subject | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Declarative Memory Encoding | Word-paired associations | 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. | 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 | 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. | EEG data *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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | Before and after each night of study session, up to 24 weeks from enrollment for each subject |