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

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial alternating current stimulation
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Theta Stimulation Group

Delta Stimulation Group

Arm Description

This group will receive 6 Hz (theta) stimulation

This group will receive 1 Hz (delta) stimulation

Outcomes

Primary Outcome Measures

Divided Attention Performance
Divided attention was assessed as the difficulty level achieved during perceptual discrimination performance while participants were engaged in the Akili AKL-T01 task. Higher is better.
Divided Attention Performance
Divided attention was assessed as the difficulty level achieved during perceptual discrimination performance while participants were engaged in the Akili AKL-T01 task. Higher is better.
Sustained Attention Performance
Sustained attention was assessed via response times to visual targets during the continuous performance task. Lower is better.
Sustained Attention Performance
Sustained attention was assessed via response times to visual targets during the continuous performance task. Lower is better.
Working Memory Performance
Working memory was assessed as the average maximum number correct from the ACE-X span tasks - memory for order of illuminated squares.
Working Memory Performance
Working memory was assessed as the average maximum number correct from the ACE-X span tasks - memory for order of illuminated squares

Secondary Outcome Measures

Instrumental Activities of Daily Living (IADL)
Scores on the IADL will be assessed pre and post intervention. Higher scores are better (minimum = 0, maximum = 4).
Instrumental Activities of Daily Living (IADL)
Scores on the IADL will be assessed pre and post intervention. Higher scores are better (minimum = 0, maximum = 4).

Full Information

First Posted
November 10, 2020
Last Updated
April 19, 2023
Sponsor
University of California, San Francisco
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04647032
Brief Title
Enhancing Cognitive Control in Mild Cognitive Impairment Via Non-invasive Brain Stimulation
Official Title
Enhancing Cognitive Control in Mild Cognitive Impairment Via Non-invasive Brain Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 11, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute on Aging (NIA)

4. Oversight

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
Data Monitoring Committee
Yes

5. 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).
Detailed Description
30 older adults aged 60-80 years with md-aMCI were randomized to 8 sessions of transcranial alternating current stimulation (tACS) with simultaneous cognitive control training (CCT). The intervention took place within the participant's home without direct researcher assistance. Half of the participants received prefrontal theta tACS during CCT and the other half received control tACS. Outcomes were assessed pre and post intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Theta Stimulation Group
Arm Type
Experimental
Arm Description
This group will receive 6 Hz (theta) stimulation
Arm Title
Delta Stimulation Group
Arm Type
Active Comparator
Arm Description
This group will receive 1 Hz (delta) stimulation
Intervention Type
Device
Intervention Name(s)
Transcranial alternating current stimulation
Intervention Description
Transcranial alternating current stimulation (tACS) will be applied across the prefrontal cortex near electrodes coordinates AF3/AF4
Primary Outcome Measure Information:
Title
Divided Attention Performance
Description
Divided attention was assessed as the difficulty level achieved during perceptual discrimination performance while participants were engaged in the Akili AKL-T01 task. Higher is better.
Time Frame
Post-tACS (1-day follow-up), approximately 1 week after baseline
Title
Divided Attention Performance
Description
Divided attention was assessed as the difficulty level achieved during perceptual discrimination performance while participants were engaged in the Akili AKL-T01 task. Higher is better.
Time Frame
Post-tACS (1-month follow-up), approximately 1 month after baseline
Title
Sustained Attention Performance
Description
Sustained attention was assessed via response times to visual targets during the continuous performance task. Lower is better.
Time Frame
Post-tACS (1-day follow-up), approximately 1 week after baseline
Title
Sustained Attention Performance
Description
Sustained attention was assessed via response times to visual targets during the continuous performance task. Lower is better.
Time Frame
Post-tACS (1-month follow-up), approximately 1 month after baseline
Title
Working Memory Performance
Description
Working memory was assessed as the average maximum number correct from the ACE-X span tasks - memory for order of illuminated squares.
Time Frame
Post-tACS (1-day follow-up), approximately 1 week after baseline
Title
Working Memory Performance
Description
Working memory was assessed as the average maximum number correct from the ACE-X span tasks - memory for order of illuminated squares
Time Frame
Post-tACS (1-month follow-up), approximately 1 month after baseline
Secondary Outcome Measure Information:
Title
Instrumental Activities of Daily Living (IADL)
Description
Scores on the IADL will be assessed pre and post intervention. Higher scores are better (minimum = 0, maximum = 4).
Time Frame
Post-tACS (1-day follow-up), approximately 1 week after baseline
Title
Instrumental Activities of Daily Living (IADL)
Description
Scores on the IADL will be assessed pre and post intervention. Higher scores are better (minimum = 0, maximum = 4).
Time Frame
Post-tACS (1-month follow-up), approximately 1 month after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore Zanto, Ph.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The dataset includes self-reported information, behavioral and electrophysiological data. The final dataset will be stripped of identifiers prior to release for sharing, thereby anonymizing the data. We will make the anonymized data available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to attempt to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. This will be in accordance with human subject regulations.
IPD Sharing Time Frame
The data will be available after the results have been determined and the study researchers are unblinded. The data will be available indefinitely upon request.
IPD Sharing Access Criteria
Contact PI.

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

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