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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04647032
• Other study ID #: 132026a
• Secondary ID: R21AG062395
• Status: Completed
• Phase: N/A
• Start date: January 11, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: April 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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