Clinical trial NCT03112902: 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
Overall status: TERMINATED
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Change in Electro-encephalogram (EEG) Power of Slow Wave Oscillations
timeFrame: Before and after each night of study session, up to 24 weeks from enrollment for each subject
Secondary outcomes:
measure: Change in Declarative Memory Encoding
timeFrame: Before and after each night of study session, up to 24 weeks from enrollment for each subject.
measure: Change in Procedural Memory Encoding *No Processing of Data Occurred to Provide Information About This Outcome Measure.
timeFrame: Before and after each night of study session, up to 24 weeks from enrollment for each subject
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.
timeFrame: Before and after each night of study session, up to 24 weeks from enrollment for each subject
measure: Change in Fast and Slow Spindle Numbers During Sleep *No Processing of Data Occurred to Provide Information About This Outcome Measure.
timeFrame: Before and after each night of study session, up to 24 weeks from enrollment for each subject
measure: Change in Slow Wave Coherence *No Processing of Data Occurred to Provide Information About This Outcome Measure.
timeFrame: Before and after each night of study session, up to 24 weeks from enrollment for each subject
measure: Change in Slow Wave Power *No Processing of Data Occurred to Provide Information About This Outcome Measure.
timeFrame: Before and after each night of study session, up to 24 weeks from enrollment for each subject
measure: Change in Sleep Architecture as Measured by Self Reported Sleep Timing *No Processing of Data Occurred to Provide Information About This Outcome Measure.
timeFrame: Before and after each night of study session, up to 24 weeks from enrollment for each subject
measure: Change in Hospital Anxiety and Depression Scale (HADS) *No Processing of Data Occurred to Provide Information About This Outcome Measure.
timeFrame: Before and after each night of study session, up to 24 weeks from enrollment for each subject
measure: Change in Clinical Global Impression of Change (CGIC) *No Processing of Data Occurred to Provide Information About This Outcome Measure.
timeFrame: Before and after each night of study session, up to 24 weeks from enrollment for each subject
measure: Change in Battery of Working Memory Tasks *No Processing of Data Occurred to Provide Information About This Outcome Measure.
timeFrame: Before and after each night of study session, up to 24 weeks from enrollment for each subject
measure: Change in Battery of Attention Tasks *No Processing of Data Occurred to Provide Information About This Outcome Measure.
timeFrame: Before and after each night of study session, up to 24 weeks from enrollment for each subject
measure: Change in Battery of Visuospatial Processing Tasks *No Processing of Data Occurred to Provide Information About This Outcome Measure.
timeFrame: Before and after each night of study session, up to 24 weeks from enrollment for each subject
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado AMC
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Brice McConnell, MD
role: PRINCIPAL_INVESTIGATOR
References: