- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05380739
Memory Training and Neural Plasticity (WMTrain)
November 17, 2023 updated by: Alexandru Iordan, University of Michigan
Working Memory Training and Neural Plasticity in Mild Cognitive Impairment
This study will evaluate the efficacy of working memory training in older adults with amnestic mild cognitive impairment (MCI).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alexandru Iordan, Ph.D
- Phone Number: 734-764-2909
- Email: adiordan@umich.edu
Study Contact Backup
- Name: Nayiri Sagherian
- Phone Number: 734-647-3704
- Email: nasagher@umich.edu
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan
-
Principal Investigator:
- Alexandru Iordan, Ph.D
-
Contact:
- Alexandru Iordan, Ph.D
- Phone Number: 734-764-2909
- Email: adiordan@umich.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: In-Person, MCI
Participants diagnosed with MCI will undergo 10 sessions of WM training in person.
|
A 10-session working memory (WM) training program
|
Active Comparator: Online, MCI
Participants diagnosed with MCI will undergo 10 sessions of WM training online.
|
A 10-session working memory (WM) training program
|
Active Comparator: Online, Healthy
Cognitively intact older adults will undergo 10 sessions of WM training online.
|
A 10-session working memory (WM) training program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gains in WM training task performance
Time Frame: 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 weeks
|
Changes in brain activation within the WM network
Time Frame: 2 weeks
|
Univariate analyses via fMRI and fNIRS, respectively, using units of brain activation (i.e., contrast estimates)
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in criterion (fMRI) WM task performance
Time Frame: 2 weeks
|
Analyses of WM performance indexed as percent accuracy
|
2 weeks
|
Changes in functional connectivity within and between canonical brain networks
Time Frame: 2 weeks
|
Graph theory analysis via fMRI and fNIRS, respectively, using measures of connectivity strength (i.e., correlation coefficients)
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alexandru Iordan, Ph.D., University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 7, 2022
Primary Completion (Estimated)
September 1, 2024
Study Completion (Estimated)
September 1, 2024
Study Registration Dates
First Submitted
April 27, 2022
First Submitted That Met QC Criteria
May 13, 2022
First Posted (Actual)
May 19, 2022
Study Record Updates
Last Update Posted (Estimated)
November 20, 2023
Last Update Submitted That Met QC Criteria
November 17, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00199574
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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