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Trial record 9 of 18 for:    Recruiting Studies | sleep | within 50 miles of Denver, Colorado, U.S.

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

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ClinicalTrials.gov Identifier: NCT03112902
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Device: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Other
Official Title: Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance
Actual Study Start Date : March 7, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Active Comparator: Effects of tACS during slow wave sleep (SWS)- Phasic 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.

Active Comparator: Effects of tACS during SWS- Standard 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.

Sham Comparator: Effects of tACS during SWS- Sham 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.

Active Comparator: Effects of tACS during SWS- Nested 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.

Active Comparator: Effects of tACS during SWS- Standard2 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.

Sham Comparator: Effects of tACS during SWS- Sham2 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.

Active Comparator: Effects of tACS during SWS- Older Adults Active 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.

Sham Comparator: Effects of tACS during SWS- Older Adults Sham 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.

Active Comparator: Effects of tACS during SWS- MCI Active 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.

Sham Comparator: Effects of tACS during SWS- MCI Sham 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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in declarative memory encoding [ Time Frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject ]
    Word-paired associations

  2. Change in procedural memory encoding [ Time Frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject ]
    Finger tapping task

  3. Change in sleep architecture as measured by minutes in each stage of sleep [ Time Frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject ]
    EEG data

  4. Change in fast and slow spindle numbers during sleep [ Time Frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject ]
    EEG data

  5. Change in slow wave coherence [ Time Frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject ]
    EEG data

  6. Change in slow wave power [ Time Frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject ]
    EEG data

  7. Change in sleep architecture as measured by self reported sleep timing [ Time Frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject ]
    Sleep diary for subjective experience

  8. Change in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject ]
    Mood outcome

  9. Change in Clinical Global Impression of Change (CGIC) [ Time Frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject ]
    Global assessment

  10. Change in battery of working memory tasks [ Time Frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject ]
    Assessment of working memory

  11. Change in battery of attention tasks [ Time Frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject ]
    Assessment of attention

  12. Change in battery of visuospatial processing tasks [ Time Frame: Before and after each night of study session, up to 24 weeks from enrollment for each subject ]
    Assessment of visuospatial ability



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 18-80
  • 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
  • rapid eye movement (REM)-sleep behavior disorder
  • narcolepsy
  • restless legs syndrome
  • currently pregnant or trying to become pregnant during the study period
  • diagnosis of cognitive impairment *cognitive impairment required for MCI arms

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112902


Contacts
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Contact: Nicola Haakonsen 303-724-4644 Nicola.Haakonsen@ucdenver.edu

Locations
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United States, Colorado
University of Colorado AMC Recruiting
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Brice McConnell, MD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03112902     History of Changes
Other Study ID Numbers: 16-1875
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders