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

NCT ID: NCT03112902

Last Updated: 2021-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-07

Study Completion Date

2021-05-04

Brief Summary

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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.

Detailed Description

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Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brice McConnell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado AMC

Aurora, Colorado, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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16-1875

Identifier Type: -

Identifier Source: org_study_id