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

University of Colorado Denver (CU Denver)

Status: Terminated

Conditions: Mild Cognitive Impairment

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03112902

16-1875

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 10 patient groups

Effects of tACS during SWS- Standard/Nested 1

Active Comparator group

Description:

This is a triple cross-over with a sham control condition; the standard tACS administered first, then Nested, then sham.

Treatment:

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

Effects of tACS during SWS- Older Adults Active 1

Active Comparator group

Description:

This is a double cross-over with a sham control condition; the tACS administered first, then the sham

Treatment:

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

Effects of tACS during SWS- MCI Active 1

Active Comparator group

Description:

This is a cross-over with a sham control condition; the standard tACS administered first, then sham.

Treatment:

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

Effects of tACS during SWS- Standard/Nested 2

Active Comparator group

Description:

This is a triple cross-over with a sham control condition; the standard tACS administered first, then sham, then nested tACS.

Treatment:

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

Effects of tACS during SWS- Standard/Nested 3

Active Comparator group

Description:

This is a triple cross-over with a sham control condition; the sham tACS administered first, then nested tACS, then standard tACS.

Treatment:

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

Effects of tACS during SWS- Older Adults Active 2

Active Comparator group

Description:

This is a double cross-over with a sham control condition; the sham administered first, then the tACS.

Treatment:

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

Effects of tACS during SWS- MCI Active 2

Active Comparator group

Description:

This is a cross-over with a sham control condition; the sham administered first, then standard tACS.

Treatment:

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

Effects of tACS during SWS- Standard/Nested 4

Active Comparator group

Description:

This is a triple cross-over with a sham control condition; the sham tACS administered first, then standard tACS, then nested tACS.

Treatment:

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

Effects of tACS during SWS- Standard/Nested 5

Active Comparator group

Description:

This is a triple cross-over with a sham control condition; the nested tACS administered first, then sham, then standard tACS.

Treatment:

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

Effects of tACS during SWS- Standard/Nested 6

Active Comparator group

Description:

This is a triple cross-over with a sham control condition; the nested tACS administered first, then standard tACS, then sham.

Treatment:

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