- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04362696
Improving Working Memory in Older Adults
October 18, 2023 updated by: Robert Reinhart, Boston University Charles River Campus
Improving Working Memory in Older Adults by Restoring Large-Scale Cortical Interactions
The research program will evaluate the theoretical claim that age-related memory and cognitive decline in humans result from the inefficient orchestration of rhythmic activity within large-scale cortical networks.
The results will contribute to the basic science groundwork for developing future non-pharmacological interventions aimed at boosting memory and cognition in aging and clinical populations.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
We hypothesize that aged-related memory and cognitive impairments emerge from large-scale functional dysconnectivity, and by stimulating the brain noninvasively with extremely weak levels of electrical current, we may be able to re-synchronize connectivity and stabilize or improve memory and cognitive function, measured behaviorally.
The experiments of this project are proposed as between-subjects, sham-controlled, and double-blind in design, and use noninvasive electroencephalographic (EEG) measurements of rhythmic brain activity.
The experimental intervention involves the application of low-intensity, high-definition, transcranial electrical current stimulation while subjects perform a variety of computer-based tasks that probe memory and cognitive function.
Study Type
Interventional
Enrollment (Estimated)
570
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: Robert M. G. Reinhart, PhD
- Phone Number: (617) 353-9481
- Email: rmgr@bu.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Recruiting
- 677 Beacon St. Room 308
-
Contact:
- Robert M. G. Reinhart, PhD
- Phone Number: (617) 353-9481
- Email: rmgr@bu.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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
The following general inclusion criteria apply to all subjects: must be between the ages of 68-80 (except for Experiment 1 where subjects must be between the ages of 18-30), have normal or corrected-to-normal vision, color vision, nonpregnant, no metal implants in head, no implanted electronic devices, no history of neurological problems or head injury, no skin sensitivity, no claustrophobia, no dementia (normal Mini Mental State Examination between 24-30; Montreal Cognitive Assessment > 25), no depression (normal Beck Depression Inventory II <13; Geriatric Depression Scale < 10), and cannot be taking any psychoactive medication.
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: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: sham stimulation
|
Low-intensity and safe, noninvasive application of electrical current to the human scalp with the goal of gradually modulating levels of neuronal excitability.
|
Experimental: active stimulation
|
Low-intensity and safe, noninvasive application of electrical current to the human scalp with the goal of gradually modulating levels of neuronal excitability.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Memory performance success (sham stimulation condition)
Time Frame: During sham intervention
|
The accuracy of task performance (in percentage correct units) in the delayed-match-to-sample working memory paradigm
|
During sham intervention
|
Memory performance success (active stimulation condition)
Time Frame: During active intervention
|
The accuracy of task performance (in percentage correct unit) in the delayed-match-to-sample working memory paradigm
|
During active intervention
|
Memory performance speed (sham stimulation condition)
Time Frame: During sham intervention
|
The reaction time of task performance (in millisecond units) in the delayed-match-to-sample working memory paradigm
|
During sham intervention
|
Memory performance speed (active stimulation condition)
Time Frame: During active intervention
|
The reaction time of task performance (in millisecond units) in the delayed-match-to-sample working memory paradigm
|
During active intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
September 1, 2019
Primary Completion (Estimated)
April 30, 2024
Study Completion (Estimated)
April 30, 2024
Study Registration Dates
First Submitted
April 21, 2020
First Submitted That Met QC Criteria
April 22, 2020
First Posted (Actual)
April 27, 2020
Study Record Updates
Last Update Posted (Actual)
October 23, 2023
Last Update Submitted That Met QC Criteria
October 18, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 4230E
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
Yes
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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