Mild Cognitive Impairment
Conditions
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.
Interventions
DEVICEApplication of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance
Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 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 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 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 |
| 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 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Effects of tACS During SWS- Standard/Nested 1 Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.
This is a triple crossover: standard tACS, then nested tACS, then sham. | 2 |
| Effects of tACS During SWS- Standard/Nested 2 This is a triple crossover: nested tACS, then standard tACS, then sham. | 2 |
| Effects of tACS During SWS- Standard/Nested 3 This is a triple crossover: sham, then nested tACS, then standard tACS. | 3 |
| Effects of tACS During SWS- Standard/Nested 4 This is a triple crossover: sham, then standard tACS, then nested tACS | 1 |
| Effects of tACS During SWS- Standard/Nested 5 This is a triple crossover: nested tACS, then sham, then standard tACS | 1 |
| Effects of tACS During SWS- Standard/Nested 6 This is a triple crossover: nested tACS, then standard tACS, then sham. | 3 |
| Effects of tACS During SWS- Older Adults Active 1 Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.
This is a crossover: standard tACS, then sham. | 9 |
| Effects of tACS During SWS- Older Adults Active 2 This is a crossover: sham, then tACS. | 3 |
| Effects of tACS During SWS- MCI Active 1 Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance: Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.
This is a crossover: standard tACS, then sham. | 0 |
| Effects of tACS During SWS- MCI Active 2 This is a crossover: sham, then tACS. | 0 |
| Total | 24 |
Baseline characteristics
| Characteristic | Effects of tACS During SWS- MCI Active 1 | Total | Effects of tACS During SWS- Standard/Nested 2 | Effects of tACS During SWS- Standard/Nested 3 | Effects of tACS During SWS- Standard/Nested 4 | Effects of tACS During SWS- Standard/Nested 5 | Effects of tACS During SWS- Standard/Nested 6 | Effects of tACS During SWS- Older Adults Active 1 | Effects of tACS During SWS- Older Adults Active 2 | Effects of tACS During SWS- Standard/Nested 1 | Effects of tACS During SWS- MCI Active 2 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 7 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants | 2 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 17 Participants | 2 Participants | 3 Participants | 1 Participants | 1 Participants | 3 Participants | 4 Participants | 1 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 23 Participants | 2 Participants | 3 Participants | 1 Participants | 1 Participants | 2 Participants | 9 Participants | 3 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 22 Participants | 2 Participants | 3 Participants | 1 Participants | 1 Participants | 3 Participants | 8 Participants | 2 Participants | 2 Participants | 0 Participants |
| Region of Enrollment United States | — | 24 participants | 2 participants | 3 participants | 1 participants | 1 participants | 3 participants | 9 participants | 3 participants | 2 participants | — |
| Sex: Female, Male Female | 0 Participants | 12 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 4 Participants | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 12 Participants | 2 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 5 Participants | 1 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 | 0 / 3 | 0 / 1 | 0 / 1 | 0 / 3 | 0 / 9 | 0 / 1 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 2 | 0 / 2 | 0 / 3 | 0 / 1 | 0 / 1 | 0 / 3 | 0 / 9 | 0 / 3 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 | 0 / 3 | 0 / 1 | 0 / 1 | 0 / 3 | 0 / 9 | 0 / 3 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change in Electro-encephalogram (EEG) Power of Slow Wave Oscillations
Power of EEG data in microvolts within slow wave frequency range.
Time frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject
Population: 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
Secondary
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
Time frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject
Population: 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 the study outcome measures.
Secondary
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
Time frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject
Population: 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 the study outcome measures.
Secondary
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
Time frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject
Population: 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 the study outcome measures.
Secondary
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
Time frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject
Population: 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 the study outcome measures.
Secondary
Change in Declarative Memory Encoding
Word-paired associations
Time frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject.
Population: 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 the study outcome measures.
Secondary
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
Time frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject
Population: 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 the study outcome measures.
Secondary
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
Time frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject
Population: 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 the study outcome measures.
Secondary
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
Time frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject
Population: 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 the study outcome measures.
Secondary
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.
Time frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject
Population: 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 the study outcome measures.
Secondary
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
Time frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject
Population: 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 the study outcome measures.
Secondary
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
Time frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject
Population: 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 the study outcome measures.
Secondary
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
Time frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject
Population: 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 the study outcome measures.