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

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT04647032
Collaborator
National Institute on Aging (NIA) (NIH)
30
Enrollment
1
Location
2
Arms
16.6
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Transcranial alternating current stimulation
 N/A

Study Design

Study Type:
Interventional
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 :
Jan 11, 2021
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
May 31, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Change in Divided Attention [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 [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 [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 [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 [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 [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) [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) [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

Criteria

Ages Eligible for Study:
60 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 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

  • Principal Investigator: Theodore Zanto, Ph.D., University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT04647032
Other Study ID Numbers:
  • 132026a
  • R21AG062395
First Posted:
Nov 30, 2020
Last Update Posted:
Aug 4, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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:
Cognitive Dysfunction

Study Results

No Results Posted as of Aug 4, 2022