Mild Cognitive ImpairmentNCT03112902
Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance
A study testing Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance in people with Mild Cognitive Impairment, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2018to 4 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18-85
- Native English speakers
- Neurological diagnosis of amnestic mild cognitive impairment (aMCI)
Who cannot join
- brain tumors
- skull defects
- epilepsy
- metal implants/devices above the neck
- eczema or sensitive skin
- insomnia
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive PerformanceDevice
Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.
| Study group | Role | What they receive |
|---|---|---|
| Effects of tACS during SWS- Standard/Nested 1 | Active comparator | This is a triple cross-over with a sham control condition; the standard tACS administered first, then Nested, then sham. Receives: Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance |
| Effects of tACS during SWS- Older Adults Active 1 | Active comparator | This is a double cross-over with a sham control condition; the tACS administered first, then the sham Receives: Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance |
| Effects of tACS during SWS- MCI Active 1 | Active comparator | This is a cross-over with a sham control condition; the standard tACS administered first, then sham. Receives: Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance |
| Effects of tACS during SWS- Standard/Nested 2 | Active comparator | This is a triple cross-over with a sham control condition; the standard tACS administered first, then sham, then nested tACS. Receives: Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance |
| Effects of tACS during SWS- Standard/Nested 3 | Active comparator | This is a triple cross-over with a sham control condition; the sham tACS administered first, then nested tACS, then standard tACS. Receives: Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance |
| Effects of tACS during SWS- Older Adults Active 2 | Active comparator | This is a double cross-over with a sham control condition; the sham administered first, then the tACS. Receives: Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance |
| Effects of tACS during SWS- MCI Active 2 | Active comparator | This is a cross-over with a sham control condition; the sham administered first, then standard tACS. Receives: Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance |
| Effects of tACS during SWS- Standard/Nested 4 | Active comparator | This is a triple cross-over with a sham control condition; the sham tACS administered first, then standard tACS, then nested tACS. Receives: Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance |
| Effects of tACS during SWS- Standard/Nested 5 | Active comparator | This is a triple cross-over with a sham control condition; the nested tACS administered first, then sham, then standard tACS. Receives: Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance |
| Effects of tACS during SWS- Standard/Nested 6 | Active comparator | This is a triple cross-over with a sham control condition; the nested tACS administered first, then standard tACS, then sham. Receives: Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Electro-encephalogram (EEG) Power of Slow Wave Oscillations
Power of EEG data in microvolts within slow wave frequency range.
Measured: Before and after each night of study session, up to 24 weeks from enrollment for each subject
Secondary outcomes (12)
Change in Declarative Memory Encoding
Word-paired associations
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Before and after each night of study session, up to 24 weeks from enrollment for each subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start7 Mar 2018
- Primary completion4 May 2021
- Study completion4 May 2021
Why it stopped: Compelling insights impacting the scientific rationale
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brice McConnell, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112902
- Sponsor's protocol ID
- 16-1875
- Status last verified
- Dec 2021
- First submitted
- 24 Mar 2017
- Last updated
- 17 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance
- ClinicalTrials.gov ID
- NCT03112902
- Acronym / sponsor ID
- 16-1875
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Compelling insights impacting the scientific rationale
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 13 Apr 2017 (actual)
- Results
- Posted 21 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Effects of tACS during SWS- Standard/Nested 1 | Active comparator | Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive PerformanceThis 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 | Active comparator | Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive PerformanceThis 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 | Active comparator | Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive PerformanceThis is a cross-over with a sham control condition; the standard tACS administered first, then sham. |
| Effects of tACS during SWS- Standard/Nested 2 | Active comparator | Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive PerformanceThis 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 3 | Active comparator | Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive PerformanceThis 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- Older Adults Active 2 | Active comparator | Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive PerformanceThis is a double cross-over with a sham control condition; the sham administered first, then the tACS. |
| Effects of tACS during SWS- MCI Active 2 | Active comparator | Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive PerformanceThis is a cross-over with a sham control condition; the sham administered first, then standard tACS. |
| Effects of tACS during SWS- Standard/Nested 4 | Active comparator | Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive PerformanceThis is a triple cross-over with a sham control condition; the sham tACS administered first, then standard tACS, then nested tACS. |
| Effects of tACS during SWS- Standard/Nested 5 | Active comparator | Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive PerformanceThis 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- Standard/Nested 6 | Active comparator | Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive PerformanceThis is a triple cross-over with a sham control condition; the nested tACS administered first, then standard tACS, then sham. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 18-85
- Native English speakers
- Neurological diagnosis of amnestic mild cognitive impairment (aMCI)
Key exclusion criteria (10 listed)
- brain tumors
- skull defects
- epilepsy
- metal implants/devices above the neck
- eczema or sensitive skin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive PerformanceTranscranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture. | Device | Effects of tACS during SWS- MCI Active 1, Effects of tACS during SWS- MCI Active 2, 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- 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 |
Primary outcome
Change in Electro-encephalogram (EEG) Power of Slow Wave Oscillations
Time frame: 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.
12 secondary outcomes
Change in Declarative Memory Encoding
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brice McConnell, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance in people with Mild Cognitive Impairment, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Electro-encephalogram (EEG) Power of Slow Wave Oscillations (time frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.