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

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • 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

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
Intervention / Treatment
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

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

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

University of Colorado, Denver

Investigators

  • 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)

March 7, 2018

Primary Completion (Actual)

May 4, 2021

Study Completion (Actual)

May 4, 2021

Study Registration Dates

First Submitted

March 24, 2017

First Submitted That Met QC Criteria

April 7, 2017

First Posted (Actual)

April 13, 2017

Study Record Updates

Last Update Posted (Actual)

December 17, 2021

Last Update Submitted That Met QC Criteria

December 8, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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