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

December 8, 2021 updated by: University of Colorado, Denver
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado AMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Device: 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.
Active Comparator: 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
Device: 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.
Active Comparator: 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.
Device: 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.
Active Comparator: 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.
Device: 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.
Active Comparator: 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.
Device: 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.
Active Comparator: 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.
Device: 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.
Active Comparator: 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.
Device: 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.
Active Comparator: 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.
Device: 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.
Active Comparator: 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.
Device: 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.
Active Comparator: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Before and after each night of study session, up to 24 weeks from enrollment for each subject

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Declarative Memory Encoding
Time Frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject.
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.
Time Frame: 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
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
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.
Time Frame: 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
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
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.
Time Frame: 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
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
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.
Time Frame: 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
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
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.
Time Frame: 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
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
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.
Time Frame: 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
Before and after each night of study session, up to 24 weeks from enrollment for each subject

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brice McConnell, MD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 4, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 4, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-1875

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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