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

University of Colorado, Denver1 site in 1 country24 target enrollmentMarch 7, 2018

ConditionsMild Cognitive Impairment

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Mild Cognitive Impairment
Sponsor: University of Colorado, Denver
Enrollment: 24
Locations: 1
Primary Endpoint: Change in Electro-encephalogram (EEG) Power of Slow Wave Oscillations
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 7, 2018

End Date

May 4, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

University of Colorado, Denver

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Ages 18-85
•Native English speakers
•Neurological diagnosis of amnestic mild cognitive impairment (aMCI)

Exclusion Criteria

•brain tumors
•skull defects
•metal implants/devices above the neck
•eczema or sensitive skin
•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

Outcomes

Primary Outcomes

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 Outcomes

Change in Declarative Memory Encoding(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.(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.(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.(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.(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.(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.(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.(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.(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.(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.(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.(Before and after each night of study session, up to 24 weeks from enrollment for each subject)