Improving Working Memory in Older Adults

Sponsor
Boston University Charles River Campus (Other)
Overall Status
Recruiting
CT.gov ID
NCT04362696
Collaborator
(none)
570
1
2
56
10.2

Study Details

Study Description

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
  • Device: High definition transcranial electrical current stimulation
N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Sep 1, 2019
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Memory performance success (sham stimulation condition) [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) [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) [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) [During active intervention]

    The reaction time of task performance (in millisecond units) in the delayed-match-to-sample working memory paradigm

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 677 Beacon St. Room 308 Boston Massachusetts United States 02215

Sponsors and Collaborators

  • Boston University Charles River Campus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Robert Reinhart, Assistant Professor, Boston University Charles River Campus
ClinicalTrials.gov Identifier:
NCT04362696
Other Study ID Numbers:
  • 4230E
First Posted:
Apr 27, 2020
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 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:
Yes
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Mar 31, 2022