Enhancing Cognitive Control in Mild Cognitive Impairment Via Non-invasive Brain Stimulation
2 other identifiers
interventional
30
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2020
CompletedFirst Posted
Study publicly available on registry
November 30, 2020
CompletedStudy Start
First participant enrolled
January 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedResults Posted
Study results publicly available
May 11, 2023
CompletedMay 11, 2023
April 1, 2023
12 months
November 10, 2020
December 28, 2022
April 19, 2023
Conditions
Outcome Measures
Primary Outcomes (6)
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 Outcomes (2)
Instrumental Activities of Daily Living (IADL)
Post-tACS (1-day follow-up), approximately 1 week after baseline
Instrumental Activities of Daily Living (IADL)
Post-tACS (1-month follow-up), approximately 1 month after baseline
Study Arms (2)
Theta Stimulation Group
EXPERIMENTALThis group will receive 6 Hz (theta) stimulation
Delta Stimulation Group
ACTIVE COMPARATORThis group will receive 1 Hz (delta) stimulation
Interventions
Transcranial alternating current stimulation (tACS) will be applied across the prefrontal cortex near electrodes coordinates AF3/AF4
Eligibility Criteria
You may qualify if:
- 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
- z-score on immediate memory, delayed memory, fluency, processing speed, or task switch
- Self-reported memory complaint
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94158, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Theodore Zanto
- Organization
- University of California San Francisco
Study Officials
- PRINCIPAL INVESTIGATOR
Theodore Zanto, Ph.D.
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2020
First Posted
November 30, 2020
Study Start
January 11, 2021
Primary Completion
December 31, 2021
Study Completion
May 31, 2022
Last Updated
May 11, 2023
Results First Posted
May 11, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- 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.
- Access Criteria
- Contact PI.
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.