CogT pSOPT Intervention Study
Personalized Engine for Speed of Information Processing
Stanford University
50 participants
Jan 12, 2024
INTERVENTIONAL
Conditions
Summary
(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.
Eligibility
Inclusion Criteria7
- 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.
- intact score for San Diego Brief Assessment of Capacity to Consent (UBACC).
- 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.
- age 60+,
- read and understand English
- adequate visual and hearing acuity for testing by self-report,
- community-dwelling (including independent living).
Exclusion Criteria7
- current enrollment in another cognitive improvement study;
- uncontrollable major depression;
- major cerebrovascular and cardiovascular diseases (e.g., congestive heart failure, pacemaker, prior myocardial infarction);
- having an active legal guardian (indicating impaired capacity for decision making);
- currently pregnant
- 3T MRI contraindication
- 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.
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Interventions
computerized cognitive training practicing speed of processing, the difficulty will be adjusted based on real-time monitored RMSSD (parasympathetic nervous system signals)
computerized mental leisure activities on cross-word puzzle, Sudoku, and solitaire; ECG will also be applied.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06005038