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Purpose

(JUSTIFICATION: This is the R33 stage of an NIH funded R21/R33 study. R21 stage (IRB-61727) was focused on intervention development; R33 stage will focus on pilot testing the effect of the intervention. The R21 phase was not considered a NIH defined clinical trial; R33 will be considered a NIH defined clinical trial) The purpose is to develop and test the effect of a "personalized" computer-based cognitive training program. The personalized program tailors the difficulty of the training tasks using a participant's biofeedback (i.e., heart rate) and cognitive performance. Such a personalization will ensure that the participant can perform at his/her ideal training capacity. Participants will be randomized into one of 2 groups and each group will play a different version of computerized training game and have ECG collected to allow subject blinding.

Conditions

Eligibility

Eligible Ages
Over 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. criteria related to defining "mild cognitive impairment": a. Presence of memory complaint; b. Rey Auditory Verbal Learning Test delayed recall (for memory) < 59% of age-adjusted norm; c. Montreal Cognitive Assessment (for global cognition) ranged 18 and 27; d. Functional Assessment Questionnaire (for activities of daily living) < 20. 2. intact score for San Diego Brief Assessment of Capacity to Consent (UBACC). 3. if a participant is on AD medication (i.e., memantine, cholinesterase inhibitors, amyloid antibodies), antidepressants, anxiolytics, or vascular risk or diseases related medications (e.g., beta-blocker), the dose should be stable for 3 months prior to recruitment. 4. age 60+, 5. read and understand English 6. adequate visual and hearing acuity for testing by self-report, 7. community-dwelling (including independent living).

Exclusion Criteria

  1. current enrollment in another cognitive improvement study; 2. uncontrollable major depression; 3. major cerebrovascular and cardiovascular diseases (e.g., congestive heart failure, pacemaker, prior myocardial infarction); 4. having an active legal guardian (indicating impaired capacity for decision making); 5. currently pregnant 6. 3T MRI contraindication 7. Neurological conditions: Neurodegenerative disease diagnosis such as Parkinson's, Alzheimers, dementia, multiple sclerosis. Of note, other neurological conditions/injury such as stroke, seizures, traumatic brain injury, will be evaluated for inclusion/exclusion on a case-by-case basis based on event recency, severity, and recovery.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
pSOPT 		personalized cognitive training with a close-loop parasympathetic nervous system monitored component
  • Behavioral: pSOPT
    computerized cognitive training practicing speed of processing, the difficulty will be adjusted based on real-time monitored RMSSD (parasympathetic nervous system signals)
Placebo Comparator
MLA 		computerized mental leisure activities
  • Behavioral: MLA
    computerized mental leisure activities on cross-word puzzle, Sudoku, and solitaire; ECG will also be applied.

Recruiting Locations

CogT Lab, Stanford University
Palo Alto, California 94304-0000
Contact:
Sarah Therrien
650-497-8434
stherrie@stanford.edu

More Details

Status
Recruiting
Sponsor
Stanford University

Study Contact

Feng Lin, BS
6082156005
cogtlab_stanford@stanford.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.