WMTrain: Memory Training and Neural Plasticity

• Sponsor: University of Michigan (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05380739
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 10.7
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment	Behavioral: Working Memory Training	N/A

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).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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)
• Primary Purpose: Treatment
• Official Title: Working Memory Training and Neural Plasticity in Mild Cognitive Impairment
• Actual Study Start Date: Apr 7, 2022
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Feb 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: In-Person, MCI Participants diagnosed with MCI will undergo 10 sessions of WM training in person.	Behavioral: Working Memory Training; A 10-session working memory (WM) training program
Active Comparator: Online, MCI Participants diagnosed with MCI will undergo 10 sessions of WM training online.	Behavioral: Working Memory Training; A 10-session working memory (WM) training program
Active Comparator: Online, Healthy Cognitively intact older adults will undergo 10 sessions of WM training online.	Behavioral: Working Memory Training; A 10-session working memory (WM) training program

Outcome Measures

Primary Outcome Measures

1. Gains in WM training task performance [2 weeks]

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

2. Changes in brain activation within the WM network [2 weeks]

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

Secondary Outcome Measures

1. Changes in criterion (fMRI) WM task performance [2 weeks]

   Analyses of WM performance indexed as percent accuracy

2. Changes in functional connectivity within and between canonical brain networks [2 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan

Investigators

• Principal Investigator: Alexandru Iordan, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alexandru Iordan, Principal Investigator, University of Michigan
• ClinicalTrials.gov Identifier: NCT05380739
• Other Study ID Numbers: HUM00199574
• First Posted: May 19, 2022
• Last Update Posted: May 19, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Alexandru Iordan, Principal Investigator, University of Michigan: Working Memory; Training; fMRI
• Additional relevant MeSH terms: Cognitive Dysfunction

Study Results

No Results Posted as of May 19, 2022