Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Working Memory in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04362696
Recruitment Status : Recruiting
First Posted : April 27, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Robert Reinhart, Boston University Charles River Campus

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Large-scale Physiological Foundations of Memory Decline in Aging Humans Device: High definition transcranial electrical current stimulation Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Improving Working Memory in Older Adults by Restoring Large-Scale Cortical Interactions
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : April 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: active stimulation Device: High definition transcranial electrical current stimulation
Low-intensity and safe, noninvasive application of electrical current to the human scalp with the goal of gradually modulating levels of neuronal excitability.

Sham Comparator: sham stimulation Device: High definition transcranial electrical current stimulation
Low-intensity and safe, noninvasive application of electrical current to the human scalp with the goal of gradually modulating levels of neuronal excitability.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04362696


Contacts
Layout table for location contacts
Contact: Robert M. G. Reinhart, PhD (617) 353-9481 rmgr@bu.edu

Locations
Layout table for location information
United States, Massachusetts
677 Beacon St. Room 308 Recruiting
Boston, Massachusetts, United States, 02215
Contact: Robert M. G. Reinhart, PhD    (617) 353-9481    rmgr@bu.edu   
Sponsors and Collaborators
Boston University Charles River Campus
Layout table for additonal information
Responsible Party: Robert Reinhart, Assistant Professor, Boston University Charles River Campus
ClinicalTrials.gov Identifier: NCT04362696    
Other Study ID Numbers: 4230E
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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