Back to resultsCogT pSOPT Intervention Study
Primary Purpose
Mild Cognitive Impairment, Subjective Cognitive Impairment
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
pSOPT
MLA
Sponsored by
About this trial
This is an interventional prevention trial for Mild Cognitive Impairment
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- CogT Lab, Stanford UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
pSOPT
MLA
Arm Description
personalized cognitive training with a close-loop parasympathetic nervous system monitored component
computerized mental leisure activities
Outcomes
Primary Outcome Measures
composite cognitive measure
a composite score of episodic memory and executive function. Episodic memory will be assessed using the Rey Auditory Verbal Learning and Brief Visuospatial Memory tests. Alternative forms of the tests will be used to reduce practice effects.The Z-transform scores across all assessment points within each test will be developed first to derive 2 composite scores (learning and delayed recall). Executive function will be measured using the EXAMINER, a computerized test package designed for RCTs. It includes 8 tests and calculates 4 sub-domain composite scores on working memory (Dot counting and N-back), inhibition (Flanker, Continuous Performance Test, and Anti-saccades), cognitive control (Dimensional Set Shifting), and Fluency (Phonemic Fluency and Category Fluency), and an overall composite score for executive function. A composite score synthesizing EXAMINER composite score, learning, and delayed recall will be created; higher indicates better performance.
Secondary Outcome Measures
central autonomic network (CAN) functional integrity
BOLD during resting-state will be collected using a gradient echo-planar imaging sequence. The functional scans will be acquired using simultaneous multi-slice at sub-second TRs. An in-scanner camera will be used to ensure compliance. Identification of CAN involved networks for the study: a functional network template along with 268 ROIs described previously will be used. In this functional template, CAN related networks will be focused, including SN, DMN, subcortical network, and frontoparietal networks, along with ACC subregions. The data will be analyzed using the FSL software packages. fMRI preprocessing will consist of motion correction, slice-timing correction, normalization, and Gaussian spatial smoothing (FWHM 8mm). To calculate resting-state and task-related fMRI, the correlation coefficient between ROI pair across the time course will be Fisher Z-transformed and averaged to derive summary scores for network strength; higher indicates stronger network strength.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06005038
Brief Title
CogT pSOPT Intervention Study
Official Title
Personalized Engine for Speed of Information Processing
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2023 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Subjective Cognitive Impairment
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pSOPT
Arm Type
Experimental
Arm Description
personalized cognitive training with a close-loop parasympathetic nervous system monitored component
Arm Title
MLA
Arm Type
Placebo Comparator
Arm Description
computerized mental leisure activities
Intervention Type
Behavioral
Intervention Name(s)
pSOPT
Intervention Description
computerized cognitive training practicing speed of processing, the difficulty will be adjusted based on real-time monitored RMSSD (parasympathetic nervous system signals)
Intervention Type
Behavioral
Intervention Name(s)
MLA
Intervention Description
computerized mental leisure activities on cross-word puzzle, Sudoku, and solitaire; ECG will also be applied.
Primary Outcome Measure Information:
Title
composite cognitive measure
Description
a composite score of episodic memory and executive function. Episodic memory will be assessed using the Rey Auditory Verbal Learning and Brief Visuospatial Memory tests. Alternative forms of the tests will be used to reduce practice effects.The Z-transform scores across all assessment points within each test will be developed first to derive 2 composite scores (learning and delayed recall). Executive function will be measured using the EXAMINER, a computerized test package designed for RCTs. It includes 8 tests and calculates 4 sub-domain composite scores on working memory (Dot counting and N-back), inhibition (Flanker, Continuous Performance Test, and Anti-saccades), cognitive control (Dimensional Set Shifting), and Fluency (Phonemic Fluency and Category Fluency), and an overall composite score for executive function. A composite score synthesizing EXAMINER composite score, learning, and delayed recall will be created; higher indicates better performance.
Time Frame
Baseline, Week 7, and 3-month
Secondary Outcome Measure Information:
Title
central autonomic network (CAN) functional integrity
Description
BOLD during resting-state will be collected using a gradient echo-planar imaging sequence. The functional scans will be acquired using simultaneous multi-slice at sub-second TRs. An in-scanner camera will be used to ensure compliance. Identification of CAN involved networks for the study: a functional network template along with 268 ROIs described previously will be used. In this functional template, CAN related networks will be focused, including SN, DMN, subcortical network, and frontoparietal networks, along with ACC subregions. The data will be analyzed using the FSL software packages. fMRI preprocessing will consist of motion correction, slice-timing correction, normalization, and Gaussian spatial smoothing (FWHM 8mm). To calculate resting-state and task-related fMRI, the correlation coefficient between ROI pair across the time course will be Fisher Z-transformed and averaged to derive summary scores for network strength; higher indicates stronger network strength.
Time Frame
Baseline, Week 7, and 3-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Lin, BS
Phone
6082156005
Email
cogtlab_stanford@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Therrien
Phone
(650) 497-8434
Email
cogtlab_stanford@stanford.edu
Facility Information:
Facility Name
CogT Lab, Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-0000
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Therrien
Phone
650-497-8434
Email
stherrie@stanford.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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CogT pSOPT Intervention Study
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