Actively Recruiting

Phase 1
Age: 60Years +
All Genders
Healthy Volunteers
NCT06005038

CogT pSOPT Intervention Study

Led by Stanford University · Updated on 2024-05-17

50

Participants Needed

1

Research Sites

154 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

(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

Official Title

CogT pSOPT Intervention Study

Who Can Participate

Age: 60Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Presence of memory complaint
  • Rey Auditory Verbal Learning Test delayed recall less than 59% of age-adjusted norm
  • Montreal Cognitive Assessment score between 18 and 27
  • Functional Assessment Questionnaire score less than 20
  • Intact score on San Diego Brief Assessment of Capacity to Consent (UBACC)
  • Stable dose for 3 months prior to recruitment if on Alzheimer's disease medication, antidepressants, anxiolytics, or vascular-related medications
  • Age 60 years or older
  • Able to read and understand English
  • Adequate visual and hearing acuity by self-report
  • Living independently in the community
Not Eligible

You will not qualify if you...

  • Currently enrolled in another cognitive improvement study
  • Uncontrollable major depression
  • Major cerebrovascular or cardiovascular diseases such as congestive heart failure, pacemaker, or prior myocardial infarction
  • Having an active legal guardian indicating impaired decision-making capacity
  • Currently pregnant
  • Contraindications for 3T MRI
  • Diagnosed neurodegenerative diseases such as Parkinson's, Alzheimer's, dementia, or multiple sclerosis
  • Other neurological conditions like stroke, seizures, or traumatic brain injury will be evaluated case-by-case based on severity and recovery

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

CogT Lab, Stanford University

Palo Alto, California, United States, 94304-0000

Actively Recruiting

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Research Team

F

Feng Lin, BS

CONTACT

S

Sarah Therrien

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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