remTDCS: At Home Brain Stimulation Studies of Memory and Memory Awareness

Sponsor

Brooklyn College of the City University of New York (Other)

Overall Status

Recruiting

CT.gov ID

NCT04749719

Collaborator

National Institute of General Medical Sciences (NIGMS) (NIH)

Enrollment

Location

Arms

28.2

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: remotely supervised transcranial direct current stimulation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

At Home Brain Stimulation Studies of Memory and Memory Awareness

Actual Study Start Date :

Apr 15, 2021

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Aug 21, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DLPFC stimulation 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 Low levels of electrical current are applied across the scalp to induce small changes in brain activity. This is done using remote supervision.
Sham Comparator: Sham tDCS 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 Low levels of electrical current are applied across the scalp to induce small changes in brain activity. This is done using remote supervision.

Arm

Intervention/Treatment

Experimental: DLPFC stimulation

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

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

Sham Comparator: Sham tDCS

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

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

Outcome Measures

Primary Outcome Measures

Memory performance [through study completion, an average of 4 weeks]
% Correct on the Memory Task

Secondary Outcome Measures

Memory Confidence [through study completion, an average of 4 weeks]
Average % Confidence on the Memory Task

Other Outcome Measures

Metamemory Accuracy [through study completion, an average of 4 weeks]
Calibration and resolution of confidence and accuracy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brooklyn College	Brooklyn	New York	United States	11210

Sponsors and Collaborators

Brooklyn College of the City University of New York
National Institute of General Medical Sciences (NIGMS)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elizabeth Chua, Associate Professor, Brooklyn College of the City University of New York

ClinicalTrials.gov Identifier:

NCT04749719

Other Study ID Numbers:

42037
SC3GM121192

First Posted:

Feb 11, 2021

Last Update Posted:

Jul 12, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Elizabeth Chua, Associate Professor, Brooklyn College of the City University of New York

transcranial direct current stimulation

memory

metacognition

brain

Study Results

No Results Posted as of Jul 12, 2021