NCT04749719

Brief Summary

The main goal of this research is to determine the role of several brain regions in memory processes and cognitive functions. Participants will be remotely supervised via video chat while self-administering tDCS, a form of non-invasive brain stimulation. Before participating in the experiment, participants will be properly trained on use of the remote tDCS device and screened for eligibility. While using the tDCS device, participants will be engaging in tasks that assess different aspects of memory and executive functioning. By using remotely supervised tDCS while participants are completing these cognitive tasks, we will be able to make causal claims about the role of the targeted brain regions in different cognitive processes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2023

Completed
Last Updated

July 12, 2021

Status Verified

April 1, 2021

Enrollment Period

1.4 years

First QC Date

February 1, 2021

Last Update Submit

July 9, 2021

Conditions

Healthy

Keywords

transcranial direct current stimulationmemorymetacognitionbrain

Outcome Measures

Primary Outcomes (1)

  • Memory performance

    % Correct on the Memory Task

    through study completion, an average of 4 weeks

Secondary Outcomes (1)

  • Memory Confidence

    through study completion, an average of 4 weeks

Other Outcomes (1)

  • Metamemory Accuracy

    through study completion, an average of 4 weeks

Study Arms (2)

DLPFC stimulation

EXPERIMENTAL

F3-SO montage or OLE optimized with 2 mA stimulation for up to 30 min during memory and metamemory task.

Device: remotely supervised transcranial direct current stimulation

Sham tDCS

SHAM COMPARATOR

F3-SO montage or OLE optimized with sham stimulation for up to 30 min during memory and metamemory task.

Device: remotely supervised transcranial direct current stimulation

Interventions

remotely supervised transcranial direct current stimulationDEVICE

Low levels of electrical current are applied across the scalp to induce small changes in brain activity. This is done using remote supervision.

DLPFC stimulationSham tDCS

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • between the ages of 18-35
  • normal or corrected to normal vision
  • fluent in English and speaking English since age 5
  • right handed

You may not qualify if:

  • chronic skin disease or medical skin condition
  • unhealed wound or open skin on the scalp, face, neck, or forehead
  • metal or electrode implants (e.g., cochlear implants, pacemakers, metal plates, rods, or screws in their head; for complete detail, see the screening form)
  • seizures or a family history of seizures, or are taking medications with a lowered seizure threshold
  • pregnant or lactating
  • any neurologic or psychiatric diseases
  • certain hair styles (dreadlocks, cornrows, etc) or hair coverings (e.g., wigs, hajibs, etc that will not be removed; note that a request can be made for an experimenter of a specific gender)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brooklyn College

Brooklyn, New York, 11210, United States

RECRUITING

Central Study Contacts

ELIZABETH CHUA, PHD

CONTACT

7189515000echua@brooklyn.cuny.edu

Casey Imperio, MS

CONTACT

6098464723cimperio@gradcenter.cuny.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 1, 2021

First Posted

February 11, 2021

Study Start

April 15, 2021

Primary Completion

August 31, 2022

Study Completion

August 21, 2023

Last Updated

July 12, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)