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

NCT ID: NCT04647032

Last Updated: 2023-05-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-11

Study Completion Date

2022-05-31

Brief Summary

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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

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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.

Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Theta Stimulation Group

This group will receive 6 Hz (theta) stimulation

Group Type EXPERIMENTAL

Transcranial alternating current stimulation

Intervention Type DEVICE

Transcranial alternating current stimulation (tACS) will be applied across the prefrontal cortex near electrodes coordinates AF3/AF4

Delta Stimulation Group

This group will receive 1 Hz (delta) stimulation

Group Type ACTIVE_COMPARATOR

Transcranial alternating current stimulation

Intervention Type DEVICE

Transcranial alternating current stimulation (tACS) will be applied across the prefrontal cortex near electrodes coordinates AF3/AF4

Interventions

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Transcranial alternating current stimulation

Transcranial alternating current stimulation (tACS) will be applied across the prefrontal cortex near electrodes coordinates AF3/AF4

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Theodore Zanto, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R21AG062395

Identifier Type: NIH

Identifier Source: secondary_id

View Link

132026a

Identifier Type: -

Identifier Source: org_study_id

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