CogT pSOPT Intervention Study

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

  • Mild Cognitive Impairment
  • Subjective Cognitive Impairment

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