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

Primary Purpose

Mild Cognitive Impairment

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mild Cognitive Impairment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Colorado AMC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Effects of tACS during SWS- Standard/Nested 1

Effects of tACS during SWS- Older Adults Active 1

Effects of tACS during SWS- MCI Active 1

Effects of tACS during SWS- Standard/Nested 2

Effects of tACS during SWS- Standard/Nested 3

Effects of tACS during SWS- Older Adults Active 2

Effects of tACS during SWS- MCI Active 2

Effects of tACS during SWS- Standard/Nested 4

Effects of tACS during SWS- Standard/Nested 5

Effects of tACS during SWS- Standard/Nested 6

Arm Description

This is a triple cross-over with a sham control condition; the standard tACS administered first, then Nested, then sham.

This is a double cross-over with a sham control condition; the tACS administered first, then the sham

This is a cross-over with a sham control condition; the standard tACS administered first, then sham.

This is a triple cross-over with a sham control condition; the standard tACS administered first, then sham, then nested tACS.

This is a triple cross-over with a sham control condition; the sham tACS administered first, then nested tACS, then standard tACS.

This is a double cross-over with a sham control condition; the sham administered first, then the tACS.

This is a cross-over with a sham control condition; the sham administered first, then standard tACS.

This is a triple cross-over with a sham control condition; the sham tACS administered first, then standard tACS, then nested tACS.

This is a triple cross-over with a sham control condition; the nested tACS administered first, then sham, then standard tACS.

This is a triple cross-over with a sham control condition; the nested tACS administered first, then standard tACS, then sham.

Outcomes

Primary Outcome Measures

Change in Electro-encephalogram (EEG) Power of Slow Wave Oscillations
Power of EEG data in microvolts within slow wave frequency range.

Secondary Outcome Measures

Change in Declarative Memory Encoding
Word-paired associations
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
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.
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
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
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
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
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
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
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
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
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

Full Information

First Posted
March 24, 2017
Last Updated
December 8, 2021
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT03112902
Brief Title
Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance
Official Title
Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Compelling insights impacting the scientific rationale
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
May 4, 2021 (Actual)
Study Completion Date
May 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Effects of tACS during SWS- Standard/Nested 1
Arm Type
Active Comparator
Arm Description
This is a triple cross-over with a sham control condition; the standard tACS administered first, then Nested, then sham.
Arm Title
Effects of tACS during SWS- Older Adults Active 1
Arm Type
Active Comparator
Arm Description
This is a double cross-over with a sham control condition; the tACS administered first, then the sham
Arm Title
Effects of tACS during SWS- MCI Active 1
Arm Type
Active Comparator
Arm Description
This is a cross-over with a sham control condition; the standard tACS administered first, then sham.
Arm Title
Effects of tACS during SWS- Standard/Nested 2
Arm Type
Active Comparator
Arm Description
This is a triple cross-over with a sham control condition; the standard tACS administered first, then sham, then nested tACS.
Arm Title
Effects of tACS during SWS- Standard/Nested 3
Arm Type
Active Comparator
Arm Description
This is a triple cross-over with a sham control condition; the sham tACS administered first, then nested tACS, then standard tACS.
Arm Title
Effects of tACS during SWS- Older Adults Active 2
Arm Type
Active Comparator
Arm Description
This is a double cross-over with a sham control condition; the sham administered first, then the tACS.
Arm Title
Effects of tACS during SWS- MCI Active 2
Arm Type
Active Comparator
Arm Description
This is a cross-over with a sham control condition; the sham administered first, then standard tACS.
Arm Title
Effects of tACS during SWS- Standard/Nested 4
Arm Type
Active Comparator
Arm Description
This is a triple cross-over with a sham control condition; the sham tACS administered first, then standard tACS, then nested tACS.
Arm Title
Effects of tACS during SWS- Standard/Nested 5
Arm Type
Active Comparator
Arm Description
This is a triple cross-over with a sham control condition; the nested tACS administered first, then sham, then standard tACS.
Arm Title
Effects of tACS during SWS- Standard/Nested 6
Arm Type
Active Comparator
Arm Description
This is a triple cross-over with a sham control condition; the nested tACS administered first, then standard tACS, then sham.
Intervention Type
Device
Intervention Name(s)
Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance
Intervention Description
Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.
Primary Outcome Measure Information:
Title
Change in Electro-encephalogram (EEG) Power of Slow Wave Oscillations
Description
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
Secondary Outcome Measure Information:
Title
Change in Declarative Memory Encoding
Description
Word-paired associations
Time Frame
Before and after each night of study session, up to 24 weeks from enrollment for each subject.
Title
Change in Procedural Memory Encoding *No Processing of Data Occurred to Provide Information About This Outcome Measure.
Description
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
Title
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.
Description
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
Title
Change in Fast and Slow Spindle Numbers During Sleep *No Processing of Data Occurred to Provide Information About This Outcome Measure.
Description
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
Title
Change in Slow Wave Coherence *No Processing of Data Occurred to Provide Information About This Outcome Measure.
Description
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
Title
Change in Slow Wave Power *No Processing of Data Occurred to Provide Information About This Outcome Measure.
Description
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
Title
Change in Sleep Architecture as Measured by Self Reported Sleep Timing *No Processing of Data Occurred to Provide Information About This Outcome Measure.
Description
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
Title
Change in Hospital Anxiety and Depression Scale (HADS) *No Processing of Data Occurred to Provide Information About This Outcome Measure.
Description
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
Title
Change in Clinical Global Impression of Change (CGIC) *No Processing of Data Occurred to Provide Information About This Outcome Measure.
Description
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
Title
Change in Battery of Working Memory Tasks *No Processing of Data Occurred to Provide Information About This Outcome Measure.
Description
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
Title
Change in Battery of Attention Tasks *No Processing of Data Occurred to Provide Information About This Outcome Measure.
Description
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
Title
Change in Battery of Visuospatial Processing Tasks *No Processing of Data Occurred to Provide Information About This Outcome Measure.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brice McConnell, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado AMC
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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