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Completed

NCT Number: NCT04647032

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).

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94158, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Transcranial Alternating Current Stimulation

Device

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

Primary outcomes

  1. Divided Attention Performance

    Time frame: Post-tACS (1-day follow-up), approximately 1 week after baseline

    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.

  2. Divided Attention Performance

    Time frame: Post-tACS (1-month follow-up), approximately 1 month after baseline

    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.

  3. Sustained Attention Performance

    Time frame: Post-tACS (1-day follow-up), approximately 1 week after baseline

    Sustained attention was assessed via response times to visual targets during the continuous performance task. Lower is better.

  4. Sustained Attention Performance

    Time frame: Post-tACS (1-month follow-up), approximately 1 month after baseline

    Sustained attention was assessed via response times to visual targets during the continuous performance task. Lower is better.

  5. Working Memory Performance

    Time frame: Post-tACS (1-day follow-up), approximately 1 week after baseline

    Working memory was assessed as the average maximum number correct from the ACE-X span tasks - memory for order of illuminated squares.

  6. Working Memory Performance

    Time frame: Post-tACS (1-month follow-up), approximately 1 month after baseline

    Working memory was assessed as the average maximum number correct from the ACE-X span tasks - memory for order of illuminated squares

Secondary outcomes

  1. Instrumental Activities of Daily Living (IADL)

    Time frame: Post-tACS (1-day follow-up), approximately 1 week after baseline

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

  2. Instrumental Activities of Daily Living (IADL)

    Time frame: Post-tACS (1-month follow-up), approximately 1 month after baseline

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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Nov 30, 2020
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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