Study Stopped
Compelling insights impacting the scientific rationale
Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2017
CompletedFirst Posted
Study publicly available on registry
April 13, 2017
CompletedStudy Start
First participant enrolled
March 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2021
CompletedResults Posted
Study results publicly available
July 21, 2021
CompletedDecember 17, 2021
December 1, 2021
3.2 years
March 24, 2017
May 21, 2021
December 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (12)
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 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 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 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
- +7 more secondary outcomes
Study Arms (10)
Effects of tACS during SWS- Standard/Nested 1
ACTIVE COMPARATORThis is a triple cross-over with a sham control condition; the standard tACS administered first, then Nested, then sham.
Effects of tACS during SWS- Older Adults Active 1
ACTIVE COMPARATORThis is a double cross-over with a sham control condition; the tACS administered first, then the sham
Effects of tACS during SWS- MCI Active 1
ACTIVE COMPARATORThis is a cross-over with a sham control condition; the standard tACS administered first, then sham.
Effects of tACS during SWS- Standard/Nested 2
ACTIVE COMPARATORThis is a triple cross-over with a sham control condition; the standard tACS administered first, then sham, then nested tACS.
Effects of tACS during SWS- Standard/Nested 3
ACTIVE COMPARATORThis is a triple cross-over with a sham control condition; the sham tACS administered first, then nested tACS, then standard tACS.
Effects of tACS during SWS- Older Adults Active 2
ACTIVE COMPARATORThis is a double cross-over with a sham control condition; the sham administered first, then the tACS.
Effects of tACS during SWS- MCI Active 2
ACTIVE COMPARATORThis is a cross-over with a sham control condition; the sham administered first, then standard tACS.
Effects of tACS during SWS- Standard/Nested 4
ACTIVE COMPARATORThis is a triple cross-over with a sham control condition; the sham tACS administered first, then standard tACS, then nested tACS.
Effects of tACS during SWS- Standard/Nested 5
ACTIVE COMPARATORThis is a triple cross-over with a sham control condition; the nested tACS administered first, then sham, then standard tACS.
Effects of tACS during SWS- Standard/Nested 6
ACTIVE COMPARATORThis is a triple cross-over with a sham control condition; the nested tACS administered first, then standard tACS, then sham.
Interventions
Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.
Eligibility Criteria
You may qualify if:
- Ages 18-85
- Native English speakers
- Neurological diagnosis of amnestic mild cognitive impairment (aMCI)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado AMC
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
During this trial we made compelling discoveries into the nature of slow wave sleep that undermined the rationale and data analysis plan for this trial. 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.
Results Point of Contact
- Title
- Brice McConnell
- Organization
- University of Colorado
Study Officials
- PRINCIPAL INVESTIGATOR
Brice McConnell, MD
University of Colorado, Denver
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2017
First Posted
April 13, 2017
Study Start
March 7, 2018
Primary Completion
May 4, 2021
Study Completion
May 4, 2021
Last Updated
December 17, 2021
Results First Posted
July 21, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share