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Enhancing Cognitive Control in Mild Cognitive Impairment Via Non-invasive Brain Stimulation

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ClinicalTrials.gov Identifier: NCT04647032
Recruitment Status : Active, not recruiting
First Posted : November 30, 2020
Last Update Posted : March 11, 2022
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief Summary:
The overall goal of this project is to improve cognitive control abilities in adults with mild cognitive impairment (MCI) through a form of non-invasive brain stimulation, transcranial alternating current stimulation (tACS).

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Device: Transcranial alternating current stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Cognitive Control in Mild Cognitive Impairment Via Non-invasive Brain Stimulation
Actual Study Start Date : January 11, 2021
Actual Primary Completion Date : December 31, 2021
Estimated Study Completion Date : May 31, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Theta Stimulation Group
This group will receive 6 Hz (theta) stimulation
 Device: Transcranial alternating current stimulation
Transcranial alternating current stimulation (tACS) will be applied across the prefrontal cortex near electrodes coordinates AF3/AF4
Active Comparator: Delta Stimulation Group
This group will receive 1 Hz (delta) stimulation
 Device: Transcranial alternating current stimulation
Transcranial alternating current stimulation (tACS) will be applied across the prefrontal cortex near electrodes coordinates AF3/AF4


Outcome Measures
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Primary Outcome Measures :
  1. Change in Divided Attention [ Time Frame: Pre-tACS (baseline), Post-tACS (1-day follow-up) ]
    Mean performance on a divided attention task will be compared pre and post intervention. Divided attention performance will be assessed on a tablet using the paradigm Endeavor that places simultaneous demands on sensory motor tracking and perceptual discrimination abilities.

  2. Change in Divided Attention [ Time Frame: Pre-tACS (baseline), Post-tACS (1-month follow-up) ]
    Mean performance on a divided attention task will be compared pre and post intervention. Divided attention performance will be assessed on a tablet using the paradigm Endeavor that places simultaneous demands on sensory motor tracking and perceptual discrimination abilities.

  3. Change in Sustained Attention [ Time Frame: Pre-tACS (baseline), Post-tACS (1-day follow-up) ]
    Mean performance on the sustained attention task will be compared pre and post intervention. Sustained attention performance will be assessed on a tablet using the paradigm TOVA that requires 1) responses to frequency targets (withhold infrequent) and 2) responses to infrequent targets (withhold frequent)

  4. Change in Sustained Attention [ Time Frame: Pre-tACS (baseline), Post-tACS (1-month follow-up) ]
    Mean performance on a sustained attention task will be compared pre and post intervention. Sustained attention performance will be assessed on a tablet using the paradigm TOVA that requires 1) responses to frequency targets (withhold infrequent) and 2) responses to infrequent targets (withhold frequent)

  5. Change in Working Memory [ Time Frame: Pre-tACS (baseline), Post-tACS (1-day follow-up) ]
    Mean performance on a working memory task will be compared pre and post intervention. Working memory performance will be assessed on a tablet using the paradigm ACE that characterizes working memory.

  6. Change in Working Memory [ Time Frame: Pre-tACS (baseline), Post-tACS (1-month follow-up) ]
    Mean performance on a working memory task will be compared pre and post intervention. Working memory performance will be assessed on a tablet using the paradigm ACE that characterizes working memory.


Secondary Outcome Measures :
  1. Change in Instrumental Activities of Daily Living (IADL) [ Time Frame: Pre-tACS (baseline), Post-tACS (1-day follow-up) ]
    Scores on the IADL will be assessed pre and post intervention. Higher scores are better (minimum = 0, maximum = 8).

  2. Change in Instrumental Activities of Daily Living (IADL) [ Time Frame: Pre-tACS (baseline), Post-tACS (1-month follow-up) ]
    Scores on the IADL will be assessed pre and post intervention. Higher scores are better (minimum = 0, maximum = 8).


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • English speaking
  • Grade 12 or more education
  • Normal or corrected to normal vision and hearing
  • Ability to complete cognitive tasks
  • Ability to cooperate and comply with all study procedures
  • Ability to tolerate tACS
  • Montreal Cognitive Assessment score: 17-28
  • -1 z-score on immediate memory, delayed memory, fluency, processing speed, or task switch
  • Self-reported memory complaint

Exclusion Criteria:

  • Neurological or psychiatric disorders other than mild cognitive impairment
  • Receiving investigational medications or have participated in a trial with investigational medications within last 30 days
  • Family history of epilepsy
  • Implanted electronic devices (e.g., pacemaker)
  • Prior head trauma
  • Pregnant
  • IQ < 80
  • Taking cholinesterase inhibitory, memantine, or psychotropic medication
  • Taking anti-depressants or anti-anxiety medication
  • Color blind
  • Substance abuse
  • Glaucoma
  • Macular degeneration
  • Amblyopia (lazy eye)
  • Strabismus (crossed eyes)
Contacts and Locations
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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): NCT04647032


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94158
Sponsors and Collaborators
University of California, San Francisco
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Theodore Zanto, Ph.D. University of California, San Francisco
More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04647032    
Other Study ID Numbers: 132026a
R21AG062395 ( U.S. NIH Grant/Contract )
First Posted: November 30, 2020    Key Record Dates
Last Update Posted: March 11, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized IPD will be made available in accordance with NIH guidelines and IRB approval.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
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