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Memory Training and Neural Plasticity (WMTrain)

Primary Purpose

Mild Cognitive Impairment

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Working Memory Training

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Working Memory, Training, fMRI

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

MCI Diagnosis
Right-handedness
MRI-eligibility for MRI participants

Exclusion Criteria:

History of other contributing neurological or medical conditions known to affect cognitive functioning
Significant mental illness
Sensory impairments that limit ability to participate
History of alcohol or drug abuse/dependence

Sites / Locations

University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

In-Person, MCI

Online, MCI

Online, Healthy

Arm Description

Participants diagnosed with MCI will undergo 10 sessions of WM training in person.

Participants diagnosed with MCI will undergo 10 sessions of WM training online.

Cognitively intact older adults will undergo 10 sessions of WM training online.

Outcomes

Primary Outcome Measures

Gains in WM training task performance

Analyses of WM performance for each training session indexed as the mean set-size achieved during each training session for each participant

Changes in brain activation within the WM network

Univariate analyses via fMRI and fNIRS, respectively, using units of brain activation (i.e., contrast estimates)

Secondary Outcome Measures

Changes in criterion (fMRI) WM task performance

Analyses of WM performance indexed as percent accuracy

Changes in functional connectivity within and between canonical brain networks

Graph theory analysis via fMRI and fNIRS, respectively, using measures of connectivity strength (i.e., correlation coefficients)

Full Information

NCT ID

NCT05380739

First Posted

April 27, 2022

Last Updated

January 30, 2023

Sponsor

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT05380739

Brief Title

Memory Training and Neural Plasticity

Acronym

WMTrain

Official Title

Working Memory Training and Neural Plasticity in Mild Cognitive Impairment

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 7, 2022 (Actual)

Primary Completion Date

September 1, 2023 (Anticipated)

Study Completion Date

September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study will evaluate the efficacy of working memory training in older adults with amnestic mild cognitive impairment (MCI).

Detailed Description

Working memory (WM) is the ability to hold information actively in mind and is fundamental for higher-order cognition. This pilot study aims to (1) evaluate the efficacy of WM training in older adults with MCI and (2) understand if and how it works. The study will use behavioral and brain imaging assessments to see whether WM training changes how participants learn and remember information. Functional magnetic resonance imaging (fMRI) and functional near infrared spectroscopy (fNIRS) methods will be used. The study will also use cognitive tests and questionnaires to determine whether participants' cognitive abilities change with training. The study will enroll participants with a diagnosis of MCI as well as cognitively intact older adults (healthy controls, HC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment

Keywords

Working Memory, Training, fMRI

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Participants in the MCI group will be assigned to receive either in-person (Arm1) or online WM training (Arm2), based on their preference and availability of equipment ensuring a stable internet connection, for 10 training sessions. Participants in the HC group will receive online training (Arm3). Data for HC who received in-person training was already collected (HUM00033133). WM performance in conjunction with brain imaging will be assessed within-subject, twice pre-training (Time1 and Time2) and once post-training (Time3), as well as ~1 month after training (Follow-up). The Time1 vs. Time2 comparison will reveal task-exposure effects, whereas the Time2 vs. Time3 comparison will reveal training effects.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

In-Person, MCI

Arm Type

Active Comparator

Arm Description

Participants diagnosed with MCI will undergo 10 sessions of WM training in person.

Arm Title

Online, MCI

Arm Type

Active Comparator

Arm Description

Participants diagnosed with MCI will undergo 10 sessions of WM training online.

Arm Title

Online, Healthy

Arm Type

Active Comparator

Arm Description

Cognitively intact older adults will undergo 10 sessions of WM training online.

Intervention Type

Behavioral

Intervention Name(s)

Working Memory Training

Intervention Description

A 10-session working memory (WM) training program

Primary Outcome Measure Information:

Title

Gains in WM training task performance

Description

Analyses of WM performance for each training session indexed as the mean set-size achieved during each training session for each participant

Time Frame

2 weeks

Title

Changes in brain activation within the WM network

Description

Univariate analyses via fMRI and fNIRS, respectively, using units of brain activation (i.e., contrast estimates)

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Changes in criterion (fMRI) WM task performance

Description

Analyses of WM performance indexed as percent accuracy

Time Frame

2 weeks

Title

Changes in functional connectivity within and between canonical brain networks

Description

Graph theory analysis via fMRI and fNIRS, respectively, using measures of connectivity strength (i.e., correlation coefficients)

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: MCI Diagnosis Right-handedness MRI-eligibility for MRI participants Exclusion Criteria: History of other contributing neurological or medical conditions known to affect cognitive functioning Significant mental illness Sensory impairments that limit ability to participate History of alcohol or drug abuse/dependence

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alexandru Iordan, Ph.D

Phone

734-647-3704

adiordan@umich.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Lauren Antonucci

Phone

734-647-3704

lanooch@umich.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexandru Iordan

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexandru Iordan, Ph.D

Phone

734-647-3704

adiordan@umich.edu

First Name & Middle Initial & Last Name & Degree

Alexandru Iordan, Ph.D

12. IPD Sharing Statement

Plan to Share IPD

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Memory Training and Neural Plasticity

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