CogT pSOPT Intervention Study

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT06005038
Phase
PHASE1
Status
Recruiting
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Conditions

  • Mild Cognitive Impairment
  • Subjective Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • pSOPT — BEHAVIORAL
    computerized cognitive training practicing speed of processing, the difficulty will be adjusted based on real-time monitored RMSSD (parasympathetic nervous system signals)
  • MLA — BEHAVIORAL
    computerized mental leisure activities on cross-word puzzle, Sudoku, and solitaire; ECG will also be applied.

Study Details

(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.

Key Dates

Start date
Jan 12, 2024
Status verified
May 2024
Primary completion
Dec 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: pSOPT
    personalized cognitive training with a close-loop parasympathetic nervous system monitored component
  • Placebo Comparator: MLA
    computerized mental leisure activities

Primary Outcome Measure

composite cognitive measure [ Time Frame: Baseline, Week 7, and 3-month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
CogT Lab, Stanford UniversityPalo AltoCalifornia94304-0000
Sarah Therrien
[email protected]
650-497-8434

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CogT Lab, Stanford University· Palo Alto, CA

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