NCT06005038

CogT pSOPT Intervention Study

Personalized Engine for Speed of Information Processing

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Mild Cognitive Impairment
• Subjective Cognitive Impairment

Interventions

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

Timeline

• Start date: 2024-01-12
• Primary completion: 2026-12-01
• Completion: 2026-12-31
• First posted: 2023-08-22
• Last updated: 2024-05-17

Locations

1 site across 1 country: United States