Actively Recruiting

Phase 1
Age: 60Years +
All Genders
Healthy Volunteers
ID06005038

Personalized Engine for Speed of Information Processing Cognitive Training for Mild Cognitive Impairment

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

50

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a personalized computer-based cognitive training program aimed at older adults with mild or subjective cognitive impairment. This study focuses on testing the effects of tailoring training difficulty using a participant's heart rate and cognitive performance to optimize training capacity. The study is a randomized, double-blind trial funded by NIH and led by Stanford University. Participants will be assigned randomly to one of two groups: one group will use the personalized speed of processing training (pSOPT) where task difficulty adjusts based on real-time parasympathetic nervous system signals captured through ECG. The other group will engage in computerized mental leisure activities such as crossword puzzles, Sudoku, and solitaire, also while having ECG monitoring to maintain blinding. During the study, participants will be assessed at baseline, week 7, and three months using a composite cognitive measure to evaluate changes in cognition. Additionally, researchers will monitor the functional integrity of the central autonomic network. Participants will complete questionnaires and cognitive tests while ECG data is collected to help tailor the intervention and ensure safety. The total study period includes initial screening and follow-up assessments over a few months.

CONDITIONS

Brief Title

CogT pSOPT Intervention Study

Who Can Participate

Age: 60Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Memory complaint present
  • Rey Auditory Verbal Learning Test delayed recall below 59% of age-adjusted norm
  • Montreal Cognitive Assessment score between 18 and 27
  • Functional Assessment Questionnaire score below 20
  • Intact capacity to consent as measured by San Diego Brief Assessment of Capacity to Consent
  • Stable dose of Alzheimer's, antidepressant, anxiolytic, or vascular medications for at least 3 months prior
  • Age 60 years or older
  • Able to read and understand English
  • Adequate vision and hearing by self-report
  • Living independently in the community
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 7 weeks

Participants undergo computerized cognitive training or mental leisure activities to practice speed of processing or engage in mental exercises.

Weekly visits for up to 7 weeks

Follow-up

Duration - 3 months

Participants are monitored for cognitive changes and autonomic function after the intervention ends.

1 visit at 3 months post-treatment

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

S

Sarah Therrien

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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