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

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).

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Device: Transcranial alternating current stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Post-tACS (1-day follow-up), approximately 1 week after baseline
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.	Post-tACS (1-month follow-up), approximately 1 month after baseline
Sustained Attention Performance	Sustained attention was assessed via response times to visual targets during the continuous performance task. Lower is better.	Post-tACS (1-day follow-up), approximately 1 week after baseline
Sustained Attention Performance	Sustained attention was assessed via response times to visual targets during the continuous performance task. Lower is better.	Post-tACS (1-month follow-up), approximately 1 month after baseline
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.	Post-tACS (1-day follow-up), approximately 1 week after baseline
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	Post-tACS (1-month follow-up), approximately 1 month after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Post-tACS (1-day follow-up), approximately 1 week after baseline
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).	Post-tACS (1-month follow-up), approximately 1 month after baseline

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Theodore Zanto, Ph.D., University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: November 10, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (Actual): November 30, 2020

Study Record Updates

• Last Update Posted (Actual): May 11, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 132026a; R21AG062395 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• 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