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

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ClinicalTrials.gov Identifier: NCT03112902
Recruitment Status : Terminated (Compelling insights impacting the scientific rationale)
First Posted : April 13, 2017
Results First Posted : July 21, 2021
Last Update Posted : December 17, 2021
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Other
Official Title: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance
Actual Study Start Date : March 7, 2018
Actual Primary Completion Date : May 4, 2021
Actual Study Completion Date : May 4, 2021

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112902


Locations
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United States, Colorado
University of Colorado AMC
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Brice McConnell, MD University of Colorado, Denver
  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:
Study Protocol  [PDF] June 4, 2019
Statistical Analysis Plan  [PDF] June 6, 2021

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03112902    
Other Study ID Numbers: 16-1875
First Posted: April 13, 2017    Key Record Dates
Results First Posted: July 21, 2021
Last Update Posted: December 17, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders