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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03112902
• Other study ID #: 16-1875
• Status: Terminated
• Phase: N/A
• Start date: March 7, 2018
• Est. completion date: May 4, 2021

Study information

• Verified date: December 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: May 4, 2021
• Est. primary completion date: May 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado AMC	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Electro-encephalogram (EEG) Power of Slow Wave Oscillations	Power of EEG data in microvolts within slow wave frequency range.	Before and after each night of study session, up to 24 weeks from enrollment for each subject
Secondary	Change in Declarative Memory Encoding	Word-paired associations	Before and after each night of study session, up to 24 weeks from enrollment for each subject.
Secondary	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	Before and after each night of study session, up to 24 weeks from enrollment for each subject
Secondary	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.	Before and after each night of study session, up to 24 weeks from enrollment for each subject
Secondary	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	Before and after each night of study session, up to 24 weeks from enrollment for each subject
Secondary	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	Before and after each night of study session, up to 24 weeks from enrollment for each subject
Secondary	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	Before and after each night of study session, up to 24 weeks from enrollment for each subject
Secondary	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	Before and after each night of study session, up to 24 weeks from enrollment for each subject
Secondary	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	Before and after each night of study session, up to 24 weeks from enrollment for each subject
Secondary	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	Before and after each night of study session, up to 24 weeks from enrollment for each subject
Secondary	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	Before and after each night of study session, up to 24 weeks from enrollment for each subject
Secondary	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	Before and after each night of study session, up to 24 weeks from enrollment for each subject
Secondary	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	Before and after each night of study session, up to 24 weeks from enrollment for each subject