Clinical trial NCT04647032: Enhancing Cognitive Control in Mild Cognitive Impairment Via Non-invasive Brain Stimulation
Official title: Enhancing Cognitive Control in Mild Cognitive Impairment Via Non-invasive Brain Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-11-30
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Divided Attention Performance
timeFrame: Post-tACS (1-day follow-up), approximately 1 week after baseline
measure: Divided Attention Performance
timeFrame: Post-tACS (1-month follow-up), approximately 1 month after baseline
measure: Sustained Attention Performance
timeFrame: Post-tACS (1-day follow-up), approximately 1 week after baseline
measure: Sustained Attention Performance
timeFrame: Post-tACS (1-month follow-up), approximately 1 month after baseline
measure: Working Memory Performance
timeFrame: Post-tACS (1-day follow-up), approximately 1 week after baseline
measure: Working Memory Performance
timeFrame: Post-tACS (1-month follow-up), approximately 1 month after baseline
Secondary outcomes:
measure: Instrumental Activities of Daily Living (IADL)
timeFrame: Post-tACS (1-day follow-up), approximately 1 week after baseline
measure: Instrumental Activities of Daily Living (IADL)
timeFrame: Post-tACS (1-month follow-up), approximately 1 month after baseline
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Theodore Zanto, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: